Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT04799418
Status:
TERMINATED
Last Update Posted:
2025-07-03
First Post:
2021-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
STEM-PD Open Label Extension (OLE)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bacllc@earthlink.net', 'phone': '919-260-5528', 'title': 'Robert Black', 'organization': 'Scion NeuroStim, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study was terminated early due to lack of device effectiveness demonstrated in STEM-PD RCT (NCT04797611) prior to final outcome measures being collected for all participants enrolled in this OLE.'}}, 'adverseEventsModule': {'timeFrame': '8 months', 'description': 'The clinicaltrials.gov definitions of AE and SAE were used', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental: Passive-active', 'description': 'This group received passive treatment with the study device in a randomized controlled trial that immediately preceded this open label extension trial during which participants received active (i.e., time-varying caloric vestibular stimulation) treatment.\n\nTreatment was \\~20 minutes, 2x per day for 12 weeks, then a follow-up period without treatment for 16 weeks, then another 8 week treatment period with the active treatment.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 51, 'seriousNumAtRisk': 69, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Experimental: Active-active', 'description': 'This group received active (i.e. time-varying caloric vestibular stimulation) treatment with the study device in a randomized controlled trial that immediately preceded this open label extension trial during which participants received active treatment. Data obtained from this group was only utilized for exploratory outcome measures.\n\nTreatment was \\~20 minutes, 2x per day for 12 weeks, then a follow-up period without treatment for 16 weeks, then another 8 week treatment period with the active treatment.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 42, 'seriousNumAtRisk': 79, 'deathsNumAffected': 1, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fall', 'notes': 'secondary to a trip, gait freezing, imbalance/slipping, or orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 24, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 25, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dizziness', 'notes': 'An episode of lightheadedness, dizziness, or worsening dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nasopharyngitis', 'notes': 'cold, head cold, common cold, etc.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Medical device site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'notes': 'An incident of nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bilateral Pleural Effusions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cerebral Vascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Right Knee Replacement surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Multiple Myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Skin Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Partial Small Bowl Obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute Gastroenteritis with Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ESCHERICHIA COLI URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Weakness secondary to urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Controlled Trial (RCT) Passive Treatment', 'description': 'This group received passive treatment with the study device in a randomized controlled trial that immediately preceded this open label extension during which participants received active (i.e., time-varying caloric vestibular simulation). Data is provided for change in scores after the 12 weeks of passive treatment in the randomized controlled trial.'}, {'id': 'OG001', 'title': 'Open Label Extension (OLE) Active Treatment', 'description': 'This group received passive treatment with the study device in a randomized controlled trial that immediately preceded this open label extension during which participants received active (i.e., time-varying caloric vestibular simulation). Data is provided for change in scores after the 12 weeks of active treatment in the open label extension.'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.12', 'groupId': 'OG000', 'lowerLimit': '-33.11', 'upperLimit': '-13.12'}, {'value': '3.28', 'groupId': 'OG001', 'lowerLimit': '-8.18', 'upperLimit': '14.74'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (NCT04797611 RCT: Day 29 - Day 113; This OLE: Day 113 to Day 197)', 'description': "The primary endpoint is the change in MDS-NMS total score during the first treatment period during the open label extension (OLE) relative to the score at the end of the NCT04797611 randomized controlled trial (RCT) treatment period (day 113) for the passive-active treatment group compared to the change in MDS-NMS total score during the RCT treatment period relative to the pretreatment baseline. The MDS-NMS is 52-item rater-administered scale used to assess a wide range of non-motor symptoms in Parkinson's disease. It measures both frequency (0/never to 4/ \\>51% of the time) and severity (0/not present to 4/major distress or disturbance) of 13 domains. Each question is scored by multiplying frequency x severity. All question scores for each domain are summed, and the scores for each domain are summed to provide the Total Score (range = 0-832) with the higher score indicating greater non-motor symptom burden.", 'unitOfMeasure': 'change in score on a scale from baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This population received passive treatment during the RCT that preceded this phase of the study and active treatment in this OLE. Only participants who completed the assessments at least once during the pre-treatment baseline period and at both the RCT end of treatment visit and the end of treatment period 1 visit during this OLE are included in the results posted. Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II", 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Controlled Trial (RCT) Passive Treatment', 'description': 'This group received passive treatment with the study device in a randomized controlled trial that immediately preceded this open label extension during which participants received active (i.e., time-varying caloric vestibular simulation). Data is provided for change in scores after the 12 weeks of passive treatment in the randomized controlled trial.'}, {'id': 'OG001', 'title': 'Open Label Extension (OLE) Active Treatment', 'description': 'This group received passive treatment with the study device in a randomized controlled trial that immediately preceded this open label extension during which participants received active (i.e., time-varying caloric vestibular simulation). Data is provided for change in scores after the 12 weeks of active treatment in the open label extension.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'groupId': 'OG000', 'lowerLimit': '-1.11', 'upperLimit': '1.05'}, {'value': '0.60', 'groupId': 'OG001', 'lowerLimit': '-0.67', 'upperLimit': '1.87'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (NCT04797611 RCT: Day 29 - Day 113; this OLE: Day 113 to Day 197)', 'description': 'The MDS-UPDRS Part II is a 13-item patient-reported assessment of activities of motor aspects of experiences of daily living. Scores range between 0-52, with the higher score indicating greater impairment to activities of daily living. This secondary endpoint evaluates the change in the MDS-UPDRS Part II score obtained during the first treatment period of this open label extension (OLE) relative to the score obtained at the end of the NCT04797611 randomized controlled trial (RCT) period (day 113).', 'unitOfMeasure': 'change in score on a scale from baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This population received passive treatment during the RCT that preceded this OLE study during which they received active treatment. Only participants who completed the assessments at least once during the pre-treatment baseline period and at both the RCT end of treatment visit and the end of treatment period 1 visit during this OLE are included in the results posted. Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Clinical Global Impression - Improvement (CGI-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Controlled Trial (RCT) Passive Treatment', 'description': 'This group received passive treatment with the study device in a randomized controlled trial that immediately preceded this open label extension during which participants received active (i.e., time-varying caloric vestibular simulation). Data is provided for change after the 12 weeks of passive treatment in the randomized controlled trial.'}, {'id': 'OG001', 'title': 'Open Label Extension (OLE) Active Treatment', 'description': 'This group received passive treatment with the study device in a randomized controlled trial that immediately preceded this open label extension during which participants received active (i.e., time-varying caloric vestibular simulation). Data is provided for change after the 12 weeks of active treatment in the open label extension relative to the pre-treatment baseline in the randomized controlled trial.'}], 'classes': [{'categories': [{'title': '1 - Very Much Improved', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '2 - Much Improved', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': '3 - Minimally Improved', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': '4 - No Change', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': '5 - Minimally Worse', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': '6 - Much Worse', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': '7 - Very Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'RCT: from Baseline (Day 29) up to 3 months (Day 113); OLE: from Baseline (Day 29) up to 11 months (Day 365)', 'description': 'The CGI-I is a clinician assessment the extent of clinically meaningful change that has occurred in the patient\'s illness at day 197/365 relative to a baseline state (assessed at day 29). Changes in all aspects of Parkinson\'s disease (e.g., motor symptoms, non-motor symptoms and complications of anti-Parkinsonian medications) are considered. A "0" corresponds to no change, higher magnitude positive values correspond to greater improvements, and higher magnitude negative scores correspond to increased worsening. Scores range from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = no change, 1=minimally improved, 2=much improved, 3=very much improved).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "This population received passive treatment during the NCT04797611 RCT that preceded the active treatment received in this OLE study. Only participants who completed the assessments at least once during the RCT's pre-treatment baseline period, the RCT's end of treatment visit, and this OLE's end of treatment period 1 visit are included in the results posted. Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants."}, {'type': 'SECONDARY', 'title': "Change From Baseline in the International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination (MDS-UPDRS Part III)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Controlled Trial (RCT) Passive Treatment', 'description': 'This group received passive treatment with the study device in a randomized controlled trial that immediately preceded this open label extension during which participants received active (i.e., time-varying caloric vestibular simulation). Data is provided for change in scores after the 12 weeks of passive treatment in the randomized controlled trial.'}, {'id': 'OG001', 'title': 'Open Label Extension (OLE) Active Treatment', 'description': 'This group received passive treatment with the study device in a randomized controlled trial that immediately preceded this open label extension during which participants received active (i.e., time-varying caloric vestibular simulation). Data is provided for change in scores after the 12 weeks of active treatment in the open label extension.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '7.0'}, {'value': '-1.5', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '7.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months (NCT04797611 RCT: Day 29 - Day 113; this OLE: Day 113 to Day 197)', 'description': 'The MDS-UPDRS Part III is a 33-item assessment of motor function evaluated by a trained blinded rater. Each item has five response options linked to accepted clinical terms (0/normal, 1/slight, 2/mild, 3/moderate, and 4/severe) for a total scoring range of 0-132. Higher scores indicate more severe motor symptoms. This secondary endpoint evaluates the change in MDS-UPDRS Part III score during the first treatment period of this open label extension (OLE) relative to the score at the end of the NCT04797611 randomized controlled trial (RCT) treatment period (day 113) for the passive-active treatment group compared to the change in MDS-UPDRS Part III score during the RCT treatment period relative to the pre-treatment baseline.', 'unitOfMeasure': 'change in score on a scale from baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "This population received passive treatment during the RCT that preceded this phase of the study and active treatment in this OLE. Only participants who completed the assessments at least once during the RCT's pre-treatment baseline period and end of treatment visit and who completed the end of treatment period 1 visit during this OLE are included in the results posted. Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants."}, {'type': 'SECONDARY', 'title': "Change From Baseline in the Parkinson's Disease Quality of Life Questionnaire Summary Index (PDQ-39 SI)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Controlled Trial (RCT) Passive Treatment', 'description': 'This group received passive treatment with the study device in a randomized controlled trial that immediately preceded this open label extension during which participants received active (i.e., time-varying caloric vestibular simulation). Data is provided for change in scores after the 12 weeks of passive treatment in the randomized controlled trial.'}, {'id': 'OG001', 'title': 'Open Label Extension (OLE) Active Treatment', 'description': 'This group received passive treatment with the study device in a randomized controlled trial that immediately preceded this open label extension during which participants received active (i.e., time-varying caloric vestibular simulation). Data is provided for change in scores after the 12 weeks of active treatment in the open label extension.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.20', 'groupId': 'OG000', 'lowerLimit': '-6.93', 'upperLimit': '12.10'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '-2.68', 'upperLimit': '2.60'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months (NCT04797611 RCT: Day 29 - Day 113; this OLE: Day 113 to Day 197', 'description': "The PDQ-39 SI is a 39-item patient-reported quality of life measure that assesses how often people living with PD are affected across 8 dimensions of daily living covering: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items), and bodily discomfort (3 items). Answers for each item range from 0/never to 4/always. Each dimension is scored by summing the scores of each item, dividing that maximum possible score of all items in the dimension, and then multiplying by 100. The total score (the SI score) is the sum of all dimension scores divided by 8 and ranges from 0-100, the higher the total score the greater the health problems).\n\nThis endpoint compares the change in the PDQ-39 total score taken at the end of the RCT treatment period to the total score obtained during the OLE's first treatment period.", 'unitOfMeasure': 'change in score on a scale from baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This population received passive treatment during the RCT that preceded this phase of the study and active treatment in this OLE. Only participants who completed the assessments at least once during the pre-treatment baseline period and at both the RCT end of treatment visit and the end of treatment period 1 visit during this OLE are included in the results posted. Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in the Combined Measure of The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Parts I, II and III", 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Controlled Trial (RCT) Passive Treatment', 'description': 'This group received passive treatment with the study device in a randomized controlled trial that immediately preceded this open label extension during which participants received active (i.e., time-varying caloric vestibular simulation). Data is provided for change in scores after the 12 weeks of passive treatment in the randomized controlled trial.'}, {'id': 'OG001', 'title': 'Open Label Extension (OLE) Active Treatment', 'description': 'This group received passive treatment with the study device in a randomized controlled trial that immediately preceded this open label extension during which participants received active (i.e., time-varying caloric vestibular simulation). Data is provided for change in scores after the 12 weeks of active treatment in the open label extension.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '6.3'}, {'value': '-1.5', 'groupId': 'OG001', 'lowerLimit': '-8.8', 'upperLimit': '10.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months (NCT04797611 RCT: Day 29 - Day 113; this OLE: Day 113 to Day 197', 'description': "The MDS-UPDRS evaluates motor (Parts I and III) and non-motor (Part II) experiences and complications of Parkinson's disease (PD) to characterizes the extent and burden of disease. Each question has five response options linked to accepted clinical terms: (0/normal, 1/slight, 2/mild, 3/moderate, and 4/severe)/evaluations and are divided across Part I (13 questions, 52 possible points), Part II (13 questions, 52 possible points), and Part III (33 questions based on 18 items, several with right, left or other body distribution scores, 132 possible points). The Combined Score is the sum of the points for all three Parts and ranges from 0 to 236. The higher the score, the more progressed (i.e., worse) is the disease state. The more negative the change score the greater the symptomatic improvement.", 'unitOfMeasure': 'change in score on a scale from baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "This population received passive treatment during the RCT that preceded this phase of the study and active treatment in this OLE. Only participants who completed the assessments at least once during the RCT's pre-treatment baseline period and the RCT's end of treatment visit and at the end of this OLE's treatment period 1 visit are included in the results posted. Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Mini-Balance Evaluation Systems Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': "The Mini-BESTest is a 14-item test scored on a 3-level ordinal scale that assesses dynamic balance in terms of anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Answers to each of the 14 items range from 0/severe difficulty to 2/normal (no difficulty) for a total possible score ranging from 0 to 28 points. The lower the score the more difficulty was encountered. This measure will be evaluated as a safety outcome to assess whether device therapy negatively impacts balance or gait for participants with Parkinson's disease (day 197 score)", 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Montreal Cognitive Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': 'The MoCA assesses cognition over 6 domains: Memory, Executive function, Attention, Language, Visuospatial, and Orientation. Points across all 6 domains are summed, and this sum equals the total score (min 0 - max 30). A higher total score indicates better cognitive function; a positive score for difference in points indicates improvement. A total score of 26-30 reflects normal cognition. Mild cognitive impairment is associated with a total score of 18-25. Total scores of 10 - 17 indicate moderate cognitive impairment; a total score less than 10 shows severe cognitive impairment.\n\nThe change (difference) in the Montreal Cognitive Assessment (MoCA) total score taken at baseline and, again, at the end of treatment visit is reported. A positive change in scores indicates improvement; whereas, a negative change in scores between baseline and end of treatment indicates worsening. The more positive the change score, the greater the improvement.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Oral Symbol Digit Modality Test (Oral SDMT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': 'The oral SDMT assesses cognition that primarily evaluates processing speed and sustained attention. It involves a substitution task where the test taker pairs specific numbers with given geometric figures using a reference key. The oral version of the test allows responses to be given verbally, making it suitable for individuals with motor disabilities or speech disorders. It is scored based on the number of correct substitutions made. The scoring range for the oral version of the SDMT is from 0 to 110, where the score represents the number of correct substitutions made within 90 seconds and the maximum score is 110 points. A higher score indicates better performance, as it reflects a faster cognitive processing speed.\n\nThe change/difference in scores between the baseline and end of study treatment are reported. A positive change in scores indicates improvement. A negative change in scores indicates worsening.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Change From Baseline in the Parkinson's Disease Sleep Scale (PDSS-2)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': 'The PDSS-2 is a patient-completed clinical rating scale that assesses the frequency of sleep disturbances over the past week. Each question is scored between 0 ("never") and 4 ("very often"), and a total score is calculated by summing a patient\'s responses to each of the 15 questions (minimum 0 to maximum 60). It has three domains: 1) motor problems at night, 2) PD symptoms at night, and 3) disturbed sleep. Total score ranges from 0 to 60, with the score of each domain ranging from 0 to 20. Higher scores represent more nighttime sleep-related problems. A positive change in scores indicates worsening. A negative change in scores indicates improvement.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Epworth Sleepiness Scale (ESS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': 'The ESS is a questionnaire used to assess daytime sleepiness. The scale consists of eight questions where respondents rate their likelihood of falling asleep in various situations on a scale from 0 to 3, with 0 indicating no chance and 3 indicating a high likelihood. The total score ranges from 0 to 24. Results from 0 to 10 show average (normal) daytime sleepiness; a result under 10 may not be cause for concern or it could identify you have trouble sleeping (insomnia). A result from 11 to 24 indicates excessive (abnormal) daytime sleepiness (10-14 is mild, 15-17 is moderate, and 18 or higher is severe).\n\nA positive change in scores indicates worsening. A negative change in scores indicates improvement.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Parkinson Anxiety Scale (PAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': 'he PAS is a 12-item observer or patient-rated scale designed to measure the severity of anxiety symptoms in patients with Parkinson\'s disease (PD). It includes three subscales that evaluate persistent anxiety (1-5), anxiety episodes (6-9), and avoidance behavior (10-12). Each item is scored on a 5-point Likert scale, where a score of "0" indicates "not" or "never," and a score of "4" indicates "severe" or "almost always." The total score for each subscale is calculated by summing the scores of the respective items. The maximum score for the entire scale is 48 points. A higher score indicates more severe anxiety symptoms.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': "The FACIT-Fatigue assesses fatigue-related symptoms and their impact on daily functioning. The scale includes a five-item symptom subscale and an eight-item impact subscale, totaling 13 items.\n\nFor each item, level of fatigue is rated as 0 (Not at all) to 4 (Very much so). To score the FACIT-Fatigue, all items' ratings are summed to create a single fatigue score with a range from 0 to 52. Higher scores represent less fatigue, while lower scores indicate more fatigue.", 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Geriatric Depression Scale-15 (GDS-15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': 'The GDS-15 is a short, self-report questionnaire to identify depression in older adults. It consists of 15 items that assess mental health based on feelings over the past week. 1 point is given for any answer indicating depression; 0 is given for any answer not indicating depression. The total score is the sum of all items and points given and ranges from 0-15, with higher scores indicating more depression.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in the Movement Disorder Society Non-Motor Rating Scale (MDS-NMS) Non-Motor Fluctuations (NMF) Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': 'The MDS-NMS NMF is a rater completed subscale that assesses the degree of change (0/no change to 4/large change) in non-motor symptoms in relation to the timing of anti-parkinsonian medications across 8 domains (depression, anxiety, thinking/cognitive abilities, bladder symptoms, restlessness, pain, fatigue, and excessive sweating). The degree of change provided for each of the 8 domains are summed. This sum is then multiplied by the time spent in non-motor "off" state (1/Rarely to 4/Majority of time) to obtain the MDS-NMS NMF Total Score.\n\nTotal possible scores for this scale measure range from 0 to 334. The higher the total score, the more progressed (i.e., worse) is the disease state.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS IV) Part IV", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': 'The UPDRS measures the severity and progression of Parkinson disease. Part IV assesses motor complications and is scored with yes and no ratings. Scores range: 0-24. Higher scores are worse; 4 and below is mild while 13 and above is severe.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Zarit Burden Interview (ZBI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': 'The ZBI is a 22-item questionnaire designed to measure the extent to which a caregiver perceives their level of burden because of caretaking. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale, ranging from 0 (Never) to 4 (Nearly Always). Total scores are obtained by summing all items endorsed. Scores are interpreted as follows: 0 to 21 indicates little or no burden, 21 to 40 indicates mild to moderate burden, 41 to 60 indicates moderate to severe burden, and 61 to 88 indicates severe burden.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Change From Baseline in the Patient Reported Outcome - Parkinson's Disease (PRO-PD)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': 'he PRO-PD is a self-rating, 32 item, visual analog scale (VAS) that assesses severity of PD symptoms. Each item evaluates a common PD symptom, covering both motor and non-motor symptoms, and is scored on a range from 0 ("no problem") to 100 ("extreme problem") points. The scores for all items are summed to obtain a total score that can range from 0 to 3200. Higher scores indicate more severe symptoms or greater impact on the patient\'s life.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in The Modified Schwab and England Activities of Daily Living Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': "This single-item clinical outcome scale assesses the functional status of individuals with Parkinson's Disease (PD). It evaluates their ability to perform daily activities, ranging from complete independence to complete dependence, with scores given in 10% increments from 100% (completely independent) to 0% (bedridden). The higher the score the more independent the participant is.", 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in EncephaLogTM 3 Meter Timed Up and Go (TUG) Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': 'Encephalog is an app through which the 3 Meter TUG Test can be run to evaluate the risk of falls in adults. The patient sits in with their back against the chair back. At "go," the patient rises from the chair, walks 3 meters at a comfortable/safe pace, turns, walks back to the chair, and sits. Timing begins at "go" and stops when reseated. The test measures in seconds. Scores indicate levels of mobility and fall risk; the higher the score (i.e., the longer it takes), the worse the functional mobility and greater the risk of falls: 10 seconds or less - normal mobility; 11-20 seconds - normal limits for frail/elderly/disabled patients; 20 seconds or more - need assistance, further examination and intervention; 30 seconds or more - significant mobility issue.)', 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in EncephaLogTM Finger Tapping Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': 'EncephaLog™ is a smartphone app through which the finger tapping test is conducted. The finger tapping test provides a quantitative measure of bradykinesia. A participant taps the phone as quickly as possible for 10 seconds with their index finger. Both left and right hand are tested. Scoring counts the number of finger taps in 10 seconds. The higher the score the more severe the symptoms.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in EncephaLogTM 10m Timed Up and Go (10m TUG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': 'EncephaLog™ is a smartphone app that measures gait and that provides indication of risk of falls in adults. The patient sits in the chair with his/her back against the chair back. On the command "go," the patient rises from the chair, walks 10 meters at a comfortable and safe pace, turns, walks back to the chair and sits down. Timing begins at the instruction "go" and stops when the patient is seated. Shorter times indicate less dysfunction.\n\nScores of ten seconds or less indicate normal mobility. Scores between 11 and 20 seconds are within normal limits for frail elderly and disabled patients.\n\nScores greater than 20 seconds suggest the person may need assistance outside and indicates further examination and intervention.\n\nScores of 30 seconds or more suggest the person may be prone to falls.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Change From Baseline in Unified Parkinson's Disease Rating Scale Part I (UPDRS I)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': 'The UPDRS measures the severity and progression of Parkinson disease. Part I assesses Non-Motor Experiences of Daily Living in terms of mentation, behavior, and mood and is scored on a 0-4 rating scale. Total scores range from 0-16 with higher scores indicating more severe symptoms.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Hoehn & Yahr (H&Y)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': "The Hoehn \\& Yahr scale is used to describe the progress of Parkinson's disease. Scoring is based on the level/stage of clinical disability described by severity of motor symptoms. Stage 1: Unilateral involvement only, usually with minimal or no functional disability. Stage 1.5: Unilateral and axial involvement. Stage 2: Bilateral involvement without impairment of balance. Stage 2.5: Mild bilateral disease with recovery on pull test. Stage 3: Bilateral disease with mild to moderate disability and impaired postural reflexes; physically independent. Stage 4: Severely disabling disease, still able to walk or stand unassisted. Stage 5: Confinement to bed or wheelchair unless aided. The greater the stage description, the more advanced the disease.", 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Patient Global Impression of Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment 1', 'description': "Study participants will self-administer \\~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration."}], 'timeFrame': '8 months', 'description': "a patient determined scale to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention.The Patient Global Impression of Improvement (PGI-I) is a tool used to measure a patient's perception of their condition following treatment. It is a single-item questionnaire that asks patients to rate their perceived change in condition on a scale from 1 (very much better) to 7 (very much worse).", 'reportingStatus': 'POSTED', 'populationDescription': 'Full data collection was not completed as the study terminated prior to collection of outcome assessments for all participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: Passive-active', 'description': 'This group received passive treatment with the study device in a randomized controlled trial (RCT) that immediately preceded this open label extension (OLE ) study during which participants received active (i.e., time-varying caloric vestibular stimulation) treatment.'}, {'id': 'FG001', 'title': 'Experimental: Active-active', 'description': 'This group received active (i.e., time-varying caloric vestibular stimulation) treatment with the study device in a randomized controlled trial that immediately preceded this open label extension during which participants received active treatment. Data obtained from this group was only utilized for exploratory outcome measures.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'Completion of Treatment Period 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'Completion of Follow-Up Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Participants (active or passive) completing NCT04797611 were eligible to enter this open label extension (OLE) study to receive active devices. NCT04797611 study was completed, however this OLE study terminated early, due to company closure. Incomplete data prevented analysis. Results posted compare the group differences by outcome measure for NCT04797611 passive participants who completed this active OLE (for passive-active only). Active-active outcomes were exploratory and so are not posted.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental: Passive-active', 'description': 'This group received passive treatment with the study device in a randomized controlled trial that immediately preceded this open label extension trial during which participants received active (i.e., time-varying caloric vestibular stimulation) treatment.'}, {'id': 'BG001', 'title': 'Experimental: Active-active', 'description': 'This group received active (i.e. time-varying caloric vestibular stimulation) treatment with the study device in a randomized controlled trial that immediately preceded this open label extension trial during which participants received active treatment. Data obtained from this group was only utilized for exploratory outcome measures.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.8', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '68.5', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '68.6', 'spread': '7.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Years of Education', 'classes': [{'categories': [{'title': '> 12 Years of Education', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': '< = 12 years of Education', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'This data is derived from the Montreal Cognitive Assessment, which is performed at interim visits, and not all participants that entered the OLE completed the assessment'}], 'populationDescription': 'Participants in the passive-active group received passive treatment during the randomized control trial and active treatment during the open label extension. Participants in the active-active group received active treatment during both the randomized control trial and the open label extension. These two groups comprise all study participants that consented to participate in the open label extension prior to the early termination of the trial.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-10', 'size': 1492257, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-12T14:00', 'hasProtocol': True}, {'date': '2025-04-22', 'size': 1286864, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-28T15:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participant, care provider, investigator and outcomes assessors were all blinded to treatment allocation during the randomized controlled trial at the time of data collection in this open label extension'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants in this open label extension portion of the study receive active time-varying caloric vestibular stimulation treatment, however, participants were previously randomized to receive the active treatment or passive treatment in a previous randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'whyStopped': 'Lack of efficacy.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2021-03-11', 'resultsFirstSubmitDate': '2025-03-22', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-01', 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in the Mini-Balance Evaluation Systems Test', 'timeFrame': '8 months', 'description': "The Mini-BESTest is a 14-item test scored on a 3-level ordinal scale that assesses dynamic balance in terms of anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Answers to each of the 14 items range from 0/severe difficulty to 2/normal (no difficulty) for a total possible score ranging from 0 to 28 points. The lower the score the more difficulty was encountered. This measure will be evaluated as a safety outcome to assess whether device therapy negatively impacts balance or gait for participants with Parkinson's disease (day 197 score)"}, {'measure': 'Change From Baseline in the Montreal Cognitive Assessment', 'timeFrame': '8 months', 'description': 'The MoCA assesses cognition over 6 domains: Memory, Executive function, Attention, Language, Visuospatial, and Orientation. Points across all 6 domains are summed, and this sum equals the total score (min 0 - max 30). A higher total score indicates better cognitive function; a positive score for difference in points indicates improvement. A total score of 26-30 reflects normal cognition. Mild cognitive impairment is associated with a total score of 18-25. Total scores of 10 - 17 indicate moderate cognitive impairment; a total score less than 10 shows severe cognitive impairment.\n\nThe change (difference) in the Montreal Cognitive Assessment (MoCA) total score taken at baseline and, again, at the end of treatment visit is reported. A positive change in scores indicates improvement; whereas, a negative change in scores between baseline and end of treatment indicates worsening. The more positive the change score, the greater the improvement.'}, {'measure': 'Change From Baseline in the Oral Symbol Digit Modality Test (Oral SDMT)', 'timeFrame': '8 months', 'description': 'The oral SDMT assesses cognition that primarily evaluates processing speed and sustained attention. It involves a substitution task where the test taker pairs specific numbers with given geometric figures using a reference key. The oral version of the test allows responses to be given verbally, making it suitable for individuals with motor disabilities or speech disorders. It is scored based on the number of correct substitutions made. The scoring range for the oral version of the SDMT is from 0 to 110, where the score represents the number of correct substitutions made within 90 seconds and the maximum score is 110 points. A higher score indicates better performance, as it reflects a faster cognitive processing speed.\n\nThe change/difference in scores between the baseline and end of study treatment are reported. A positive change in scores indicates improvement. A negative change in scores indicates worsening.'}, {'measure': "Change From Baseline in the Parkinson's Disease Sleep Scale (PDSS-2)", 'timeFrame': '8 months', 'description': 'The PDSS-2 is a patient-completed clinical rating scale that assesses the frequency of sleep disturbances over the past week. Each question is scored between 0 ("never") and 4 ("very often"), and a total score is calculated by summing a patient\'s responses to each of the 15 questions (minimum 0 to maximum 60). It has three domains: 1) motor problems at night, 2) PD symptoms at night, and 3) disturbed sleep. Total score ranges from 0 to 60, with the score of each domain ranging from 0 to 20. Higher scores represent more nighttime sleep-related problems. A positive change in scores indicates worsening. A negative change in scores indicates improvement.'}, {'measure': 'Change From Baseline in Epworth Sleepiness Scale (ESS)', 'timeFrame': '8 months', 'description': 'The ESS is a questionnaire used to assess daytime sleepiness. The scale consists of eight questions where respondents rate their likelihood of falling asleep in various situations on a scale from 0 to 3, with 0 indicating no chance and 3 indicating a high likelihood. The total score ranges from 0 to 24. Results from 0 to 10 show average (normal) daytime sleepiness; a result under 10 may not be cause for concern or it could identify you have trouble sleeping (insomnia). A result from 11 to 24 indicates excessive (abnormal) daytime sleepiness (10-14 is mild, 15-17 is moderate, and 18 or higher is severe).\n\nA positive change in scores indicates worsening. A negative change in scores indicates improvement.'}, {'measure': 'Change From Baseline in the Parkinson Anxiety Scale (PAS)', 'timeFrame': '8 months', 'description': 'he PAS is a 12-item observer or patient-rated scale designed to measure the severity of anxiety symptoms in patients with Parkinson\'s disease (PD). It includes three subscales that evaluate persistent anxiety (1-5), anxiety episodes (6-9), and avoidance behavior (10-12). Each item is scored on a 5-point Likert scale, where a score of "0" indicates "not" or "never," and a score of "4" indicates "severe" or "almost always." The total score for each subscale is calculated by summing the scores of the respective items. The maximum score for the entire scale is 48 points. A higher score indicates more severe anxiety symptoms.'}, {'measure': 'Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scale', 'timeFrame': '8 months', 'description': "The FACIT-Fatigue assesses fatigue-related symptoms and their impact on daily functioning. The scale includes a five-item symptom subscale and an eight-item impact subscale, totaling 13 items.\n\nFor each item, level of fatigue is rated as 0 (Not at all) to 4 (Very much so). To score the FACIT-Fatigue, all items' ratings are summed to create a single fatigue score with a range from 0 to 52. Higher scores represent less fatigue, while lower scores indicate more fatigue."}, {'measure': 'Change From Baseline in the Geriatric Depression Scale-15 (GDS-15)', 'timeFrame': '8 months', 'description': 'The GDS-15 is a short, self-report questionnaire to identify depression in older adults. It consists of 15 items that assess mental health based on feelings over the past week. 1 point is given for any answer indicating depression; 0 is given for any answer not indicating depression. The total score is the sum of all items and points given and ranges from 0-15, with higher scores indicating more depression.'}, {'measure': 'Change in the Movement Disorder Society Non-Motor Rating Scale (MDS-NMS) Non-Motor Fluctuations (NMF) Subscale Score', 'timeFrame': '8 months', 'description': 'The MDS-NMS NMF is a rater completed subscale that assesses the degree of change (0/no change to 4/large change) in non-motor symptoms in relation to the timing of anti-parkinsonian medications across 8 domains (depression, anxiety, thinking/cognitive abilities, bladder symptoms, restlessness, pain, fatigue, and excessive sweating). The degree of change provided for each of the 8 domains are summed. This sum is then multiplied by the time spent in non-motor "off" state (1/Rarely to 4/Majority of time) to obtain the MDS-NMS NMF Total Score.\n\nTotal possible scores for this scale measure range from 0 to 334. The higher the total score, the more progressed (i.e., worse) is the disease state.'}, {'measure': "Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS IV) Part IV", 'timeFrame': '8 months', 'description': 'The UPDRS measures the severity and progression of Parkinson disease. Part IV assesses motor complications and is scored with yes and no ratings. Scores range: 0-24. Higher scores are worse; 4 and below is mild while 13 and above is severe.'}, {'measure': 'Change From Baseline in the Zarit Burden Interview (ZBI)', 'timeFrame': '8 months', 'description': 'The ZBI is a 22-item questionnaire designed to measure the extent to which a caregiver perceives their level of burden because of caretaking. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale, ranging from 0 (Never) to 4 (Nearly Always). Total scores are obtained by summing all items endorsed. Scores are interpreted as follows: 0 to 21 indicates little or no burden, 21 to 40 indicates mild to moderate burden, 41 to 60 indicates moderate to severe burden, and 61 to 88 indicates severe burden.'}, {'measure': "Change From Baseline in the Patient Reported Outcome - Parkinson's Disease (PRO-PD)", 'timeFrame': '8 months', 'description': 'he PRO-PD is a self-rating, 32 item, visual analog scale (VAS) that assesses severity of PD symptoms. Each item evaluates a common PD symptom, covering both motor and non-motor symptoms, and is scored on a range from 0 ("no problem") to 100 ("extreme problem") points. The scores for all items are summed to obtain a total score that can range from 0 to 3200. Higher scores indicate more severe symptoms or greater impact on the patient\'s life.'}, {'measure': 'Change From Baseline in The Modified Schwab and England Activities of Daily Living Scale', 'timeFrame': '8 months', 'description': "This single-item clinical outcome scale assesses the functional status of individuals with Parkinson's Disease (PD). It evaluates their ability to perform daily activities, ranging from complete independence to complete dependence, with scores given in 10% increments from 100% (completely independent) to 0% (bedridden). The higher the score the more independent the participant is."}, {'measure': 'Change From Baseline in EncephaLogTM 3 Meter Timed Up and Go (TUG) Test', 'timeFrame': '8 months', 'description': 'Encephalog is an app through which the 3 Meter TUG Test can be run to evaluate the risk of falls in adults. The patient sits in with their back against the chair back. At "go," the patient rises from the chair, walks 3 meters at a comfortable/safe pace, turns, walks back to the chair, and sits. Timing begins at "go" and stops when reseated. The test measures in seconds. Scores indicate levels of mobility and fall risk; the higher the score (i.e., the longer it takes), the worse the functional mobility and greater the risk of falls: 10 seconds or less - normal mobility; 11-20 seconds - normal limits for frail/elderly/disabled patients; 20 seconds or more - need assistance, further examination and intervention; 30 seconds or more - significant mobility issue.)'}, {'measure': 'Change From Baseline in EncephaLogTM Finger Tapping Test', 'timeFrame': '8 months', 'description': 'EncephaLog™ is a smartphone app through which the finger tapping test is conducted. The finger tapping test provides a quantitative measure of bradykinesia. A participant taps the phone as quickly as possible for 10 seconds with their index finger. Both left and right hand are tested. Scoring counts the number of finger taps in 10 seconds. The higher the score the more severe the symptoms.'}, {'measure': 'Change From Baseline in EncephaLogTM 10m Timed Up and Go (10m TUG)', 'timeFrame': '8 months', 'description': 'EncephaLog™ is a smartphone app that measures gait and that provides indication of risk of falls in adults. The patient sits in the chair with his/her back against the chair back. On the command "go," the patient rises from the chair, walks 10 meters at a comfortable and safe pace, turns, walks back to the chair and sits down. Timing begins at the instruction "go" and stops when the patient is seated. Shorter times indicate less dysfunction.\n\nScores of ten seconds or less indicate normal mobility. Scores between 11 and 20 seconds are within normal limits for frail elderly and disabled patients.\n\nScores greater than 20 seconds suggest the person may need assistance outside and indicates further examination and intervention.\n\nScores of 30 seconds or more suggest the person may be prone to falls.'}, {'measure': "Change From Baseline in Unified Parkinson's Disease Rating Scale Part I (UPDRS I)", 'timeFrame': '8 months', 'description': 'The UPDRS measures the severity and progression of Parkinson disease. Part I assesses Non-Motor Experiences of Daily Living in terms of mentation, behavior, and mood and is scored on a 0-4 rating scale. Total scores range from 0-16 with higher scores indicating more severe symptoms.'}, {'measure': 'Change From Baseline in Hoehn & Yahr (H&Y)', 'timeFrame': '8 months', 'description': "The Hoehn \\& Yahr scale is used to describe the progress of Parkinson's disease. Scoring is based on the level/stage of clinical disability described by severity of motor symptoms. Stage 1: Unilateral involvement only, usually with minimal or no functional disability. Stage 1.5: Unilateral and axial involvement. Stage 2: Bilateral involvement without impairment of balance. Stage 2.5: Mild bilateral disease with recovery on pull test. Stage 3: Bilateral disease with mild to moderate disability and impaired postural reflexes; physically independent. Stage 4: Severely disabling disease, still able to walk or stand unassisted. Stage 5: Confinement to bed or wheelchair unless aided. The greater the stage description, the more advanced the disease."}, {'measure': 'Change From Baseline in Patient Global Impression of Improvement', 'timeFrame': '8 months', 'description': "a patient determined scale to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention.The Patient Global Impression of Improvement (PGI-I) is a tool used to measure a patient's perception of their condition following treatment. It is a single-item questionnaire that asks patients to rate their perceived change in condition on a scale from 1 (very much better) to 7 (very much worse)."}], 'primaryOutcomes': [{'measure': 'Change From Baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score', 'timeFrame': '3 months (NCT04797611 RCT: Day 29 - Day 113; This OLE: Day 113 to Day 197)', 'description': "The primary endpoint is the change in MDS-NMS total score during the first treatment period during the open label extension (OLE) relative to the score at the end of the NCT04797611 randomized controlled trial (RCT) treatment period (day 113) for the passive-active treatment group compared to the change in MDS-NMS total score during the RCT treatment period relative to the pretreatment baseline. The MDS-NMS is 52-item rater-administered scale used to assess a wide range of non-motor symptoms in Parkinson's disease. It measures both frequency (0/never to 4/ \\>51% of the time) and severity (0/not present to 4/major distress or disturbance) of 13 domains. Each question is scored by multiplying frequency x severity. All question scores for each domain are summed, and the scores for each domain are summed to provide the Total Score (range = 0-832) with the higher score indicating greater non-motor symptom burden."}], 'secondaryOutcomes': [{'measure': "Change From Baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II", 'timeFrame': '3 months (NCT04797611 RCT: Day 29 - Day 113; this OLE: Day 113 to Day 197)', 'description': 'The MDS-UPDRS Part II is a 13-item patient-reported assessment of activities of motor aspects of experiences of daily living. Scores range between 0-52, with the higher score indicating greater impairment to activities of daily living. This secondary endpoint evaluates the change in the MDS-UPDRS Part II score obtained during the first treatment period of this open label extension (OLE) relative to the score obtained at the end of the NCT04797611 randomized controlled trial (RCT) period (day 113).'}, {'measure': 'Change From Baseline in the Clinical Global Impression - Improvement (CGI-I)', 'timeFrame': 'RCT: from Baseline (Day 29) up to 3 months (Day 113); OLE: from Baseline (Day 29) up to 11 months (Day 365)', 'description': 'The CGI-I is a clinician assessment the extent of clinically meaningful change that has occurred in the patient\'s illness at day 197/365 relative to a baseline state (assessed at day 29). Changes in all aspects of Parkinson\'s disease (e.g., motor symptoms, non-motor symptoms and complications of anti-Parkinsonian medications) are considered. A "0" corresponds to no change, higher magnitude positive values correspond to greater improvements, and higher magnitude negative scores correspond to increased worsening. Scores range from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = no change, 1=minimally improved, 2=much improved, 3=very much improved).'}, {'measure': "Change From Baseline in the International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination (MDS-UPDRS Part III)", 'timeFrame': '3 months (NCT04797611 RCT: Day 29 - Day 113; this OLE: Day 113 to Day 197)', 'description': 'The MDS-UPDRS Part III is a 33-item assessment of motor function evaluated by a trained blinded rater. Each item has five response options linked to accepted clinical terms (0/normal, 1/slight, 2/mild, 3/moderate, and 4/severe) for a total scoring range of 0-132. Higher scores indicate more severe motor symptoms. This secondary endpoint evaluates the change in MDS-UPDRS Part III score during the first treatment period of this open label extension (OLE) relative to the score at the end of the NCT04797611 randomized controlled trial (RCT) treatment period (day 113) for the passive-active treatment group compared to the change in MDS-UPDRS Part III score during the RCT treatment period relative to the pre-treatment baseline.'}, {'measure': "Change From Baseline in the Parkinson's Disease Quality of Life Questionnaire Summary Index (PDQ-39 SI)", 'timeFrame': '3 months (NCT04797611 RCT: Day 29 - Day 113; this OLE: Day 113 to Day 197', 'description': "The PDQ-39 SI is a 39-item patient-reported quality of life measure that assesses how often people living with PD are affected across 8 dimensions of daily living covering: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items), and bodily discomfort (3 items). Answers for each item range from 0/never to 4/always. Each dimension is scored by summing the scores of each item, dividing that maximum possible score of all items in the dimension, and then multiplying by 100. The total score (the SI score) is the sum of all dimension scores divided by 8 and ranges from 0-100, the higher the total score the greater the health problems).\n\nThis endpoint compares the change in the PDQ-39 total score taken at the end of the RCT treatment period to the total score obtained during the OLE's first treatment period."}, {'measure': "Change From Baseline in the Combined Measure of The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Parts I, II and III", 'timeFrame': '3 months (NCT04797611 RCT: Day 29 - Day 113; this OLE: Day 113 to Day 197', 'description': "The MDS-UPDRS evaluates motor (Parts I and III) and non-motor (Part II) experiences and complications of Parkinson's disease (PD) to characterizes the extent and burden of disease. Each question has five response options linked to accepted clinical terms: (0/normal, 1/slight, 2/mild, 3/moderate, and 4/severe)/evaluations and are divided across Part I (13 questions, 52 possible points), Part II (13 questions, 52 possible points), and Part III (33 questions based on 18 items, several with right, left or other body distribution scores, 132 possible points). The Combined Score is the sum of the points for all three Parts and ranges from 0 to 236. The higher the score, the more progressed (i.e., worse) is the disease state. The more negative the change score the greater the symptomatic improvement."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Open Label Extension Study', 'Medical Devices', 'Non-Motor Symptoms (NMS)', 'Non-Invasive Brain Stimulation', 'Parkinson Disease'], 'conditions': ['Parkinson Disease', "Parkinson's Disease and Parkinsonism"]}, 'descriptionModule': {'briefSummary': "This study seeks to establish the safety and efficacy of extended twice daily time-varying caloric vestibular stimulation treatments for treating symptoms associated with Parkinson's disease. Only participants who completed the STEM-PD randomized controlled trial portion (NCT04797611) are eligible to participate in the open label extension portion.", 'detailedDescription': 'Up to 220 participants will enter an open label extension study during which all study participants will receive active (i.e., time-varying caloric vestibular stimulation) treatment for 12 weeks (84 days). Study participants will be followed for 16 weeks (112 days) post treatment-cessation and then the twice daily active treatments will be re-introduced for the final 8 weeks (56 days).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completion of the study activities in the STEM-PD RCT trial (see STEM-PD RCT eligibility criteria noted below).\n* Participants must be willing and able to give consent to participate in the study trial.\n* Participants and investigators must expect that the participant will be able to remain on a stable regimen of concomitant therapies used for the management of PD motor and non-motor symptoms and not to introduce new medications used to treat motor or non-motor symptoms associated with PD during the first three months of the OLE (Day197).\n\nExclusion Criteria:\n\n* Participant anticipates being unable to attend all visits and complete all study activities.\n* Has a planned surgery scheduled to occur during the first 90 days of the OLE that would typically be followed with a prescription for pain management\n\nSTEM-PD RCT Eligibility criteria:\n\nInclusion:\n\n1. Adult participants (aged 18 - 85 years inclusive).\n2. Have been diagnosed with PD according to the UK Brain Bank Criteria (allowing for an exclusion in Step 2 for "more than one affected relative").\n3. Participants must have demonstrated a sustained positive response to DRTs (e.g., levodopa, dopamine agonists or monoamine oxidase inhibitors) defined as either good or excellent responses (50-100%) for at least one year or moderate responses (30-49)% for at least three years prior to Screen.\n4. Participant reports limitation or clinician-investigator determined limitation, based on knowledge of medical history, to one or more activities of daily living (e.g., writing, walking, bathing, dressing, eating, toileting, etc.).\n5. Participants must be able and willing to consent to participate in the study for the RCT and OLE.\n6. Participants must be willing and able to comply with study requirements.\n7. Participants must have at minimum a moderate burden of NMS (i.e., MDS-UPDRS part Ia and part Ib summed total score ≥ 9) at study screen to avoid floor effects for the primary endpoint (MDS-NMS).\n8. The principal investigator or designee must have confidence in the participant\'s ability to reliably use the TNM™ device, understand the assessments (provided in English only) and to complete the assessment battery within a given on-state period.\n9. Must have a study partner (defined as someone who sees the participant for more than one hour a day, 3x per week) that is willing to consent and participate in the trial.\n10. Participants must have capabilities to use and access smartphones for the collection of some study data and/or tablets or computers for access to telemedicine platforms.\n11. Must be willing to answer questions related to sexual interest, arousal and performance in an interview with study staff.\n\nExclusion:\n\n1. Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the study\n\n • Women of child-bearing potential (i.e., are not yet either 3 years removed from their first menopausal symptom or 12 months removed from last menses), who are not abstinent or exclusively in same sex relationships must:\n * test negative for pregnancy as indicated by a negative urine pregnancy test;\n * agree to use an approved contraception method listed in section 5.3.3 for the entirety of the RCT and OLE;\n2. Have a history or prior diagnosis of dementia or adjusted score ≤ 20 on the Montreal Cognitive Assessment (MoCA) at the screening visit.\n3. Have experienced a myocardial infarction, angina or stroke within the past 12 months or a transient ischemic attack (TIA) within 6 months.\n4. Are receiving deep brain stimulation therapy.\n5. Are treated with a pump for continuous delivery of dopamine replacement therapy.\n6. Have received MRI guided high intensity focused ultrasound within the past 12 months.\n7. Experience frequent falls (defined as 2 or more falls in the past month related to Parkinson\'s disease). Parkinson\'s falls are defined as falls associated with bradykinesia, freezing, turning, change in posture and postural dizziness and do not include accidental falls.\n8. Work night shifts.\n9. Has any significant co-morbidity or illness which in the opinion of the investigator would prevent safe participation in the study, compliance with protocol requirements or which presents with symptoms that are also common in PD.\n10. Demonstrate suicidality at screening (scores ≥ 4 on the C-SSRS Baseline in section "Suicidal Ideation" (In the past Month)). Participants that respond affirmatively to question 4 or 5 (In the past Month) should receive a referral for mental health counseling according to local site regulations and standards.\n11. Use a hearing aid that is implanted or that cannot be easily removed and replaced.\n12. Have a cochlear implant or myringotomy tubes.\n13. Have chronic tinnitus that has been ongoing for at least 3 months and causes significant impairment of communication and/or impairment of activities of daily living.\n14. Have previously been diagnosed with traumatic brain injury with ongoing sequela.\n15. Have been diagnosed with a co-morbid neurological disorder that may present with symptoms overlapping with PD (e.g., stroke, brain tumor, epilepsy, Alzheimer\'s disease, multiple sclerosis, amyotrophic lateral sclerosis, atypical Parkinsonism or aneurysm).\n16. Have been previously diagnosed with either clinically meaningful central vestibular dysfunction (lifetime) or have experienced clinically meaningful peripheral vestibular dysfunction within the last 12 months. For this purpose, clinically meaningful is defined as vestibular dysfunction which causes at least a minimal impairment in the individual activities of daily living (e.g., dressing, bathing, preparing food, conducting household chores, work or recreational activities).\n17. In the Investigator\'s opinion, currently abuse alcohol, abuse drugs (including legal, illegal or prescribed drugs) or have a history of alcohol or drug dependency within the past 5 years or use any drugs excluded as noted in the Excluded Medications List\n18. Have unresolved complications from a previous surgical procedure at the baseline visits, such as swelling or persistent pain, that requires medical intervention.\n19. Have active ear infections, perforated tympanic membrane or labyrinthitis, as identified by a general ear examination performed by medically qualified Investigators.\n\n29\\. Have a recent history of frequent ear infections (≥ 1 per year over the past two years).\n\n21\\. Are currently enrolled or have participated in another interventional clinical trial within the last 30 days.\n\n22\\. Have had eye surgery within the previous three months or ear surgery within the previous six months.'}, 'identificationModule': {'nctId': 'NCT04799418', 'briefTitle': 'STEM-PD Open Label Extension (OLE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Scion NeuroStim'}, 'officialTitle': "Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease: An Open Label Extension (OLE) Study", 'orgStudyIdInfo': {'id': 'SNS-PD-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'passive-active', 'description': 'This group received passive treatment with the study device in a randomized controlled trial (RCT) that immediately preceded this open label extension (OLE ) trial during which participants received active (i.e., time-varying caloric vestibular stimulation ) treatment.', 'interventionNames': ['Device: Open Label Extension Study']}, {'type': 'EXPERIMENTAL', 'label': 'active-active', 'description': 'This group received active (i.e., time-varying caloric vestibular stimulation) treatment with the study device in a randomized controlled trial (RCT) that immediately preceded this open label extension (OLE) trial during which participants received active treatment. Data from participants in this arm was only used for exploratory outcomes.', 'interventionNames': ['Device: Open Label Extension Study']}], 'interventions': [{'name': 'Open Label Extension Study', 'type': 'DEVICE', 'description': 'This study will investigate the safety and efficacy of extended treatments for the management of symptoms related to PD.', 'armGroupLabels': ['active-active', 'passive-active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Movement Disorder Center of Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': "Parkinson's Disease and Movement Disorder of Boca Raton", 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '32819', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Headlands Research Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': "University of Kansas Medical Center - Parkinson's Disease Center", 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Quest Research', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': "Mercy Health Saint Mary's", 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38157', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Veracity Neuroscience', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Neurological Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23601', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'Riverside Neurology Specialists', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scion NeuroStim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}