Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-01-31 @ 1:45 AM
Study NCT ID:
NCT03794661
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2018-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020329', 'term': 'Essential Tremor'}, {'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'binith.cheeran@abbott.com', 'phone': '+15122864262', 'title': 'Binith Cheeran', 'organization': 'Abbott Medical Devices Neuromodulation'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Subjects enrolled at the experienced centers in this study already had individually tailored therapy at the baseline visit.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Single Arm', 'description': 'Clinician programmer electrode screening mode tool\n\nClinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Persistent pain, tightness, or discomfort around the implanted parts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Initial jolt, or tingling stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Spine fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Extension malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Clinician programmer electrode screening mode tool\n\nClinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.37', 'spread': '1.48', 'groupId': 'OG000'}]}]}, {'title': 'Informity Programming', 'categories': [{'measurements': [{'value': '1.80', 'spread': '1.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 21 compared to baseline', 'description': "Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.", 'unitOfMeasure': 'milliampere (mA)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'PRIMARY', 'title': 'Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Clinician programmer electrode screening mode tool\n\nClinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.37', 'spread': '1.48', 'groupId': 'OG000'}]}]}, {'title': 'Informity Programming', 'categories': [{'measurements': [{'value': '2.34', 'spread': '1.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 21 compared to baseline', 'description': "Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.", 'unitOfMeasure': 'milliampere (mA)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'PRIMARY', 'title': 'Change in Therapeutic Electrical Energy Delivered (TEED) With Selected Contact at the Informity Programming Visit Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Clinician programmer electrode screening mode tool\n\nClinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '46.6', 'spread': '30.2', 'groupId': 'OG000'}]}]}, {'title': 'Informity Programming', 'categories': [{'measurements': [{'value': '65.6', 'spread': '94.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 21 compared to baseline', 'description': "TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing.", 'unitOfMeasure': 'microjoule (μJ)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'PRIMARY', 'title': 'Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Clinician programmer electrode screening mode tool\n\nClinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '46.6', 'spread': '30.2', 'groupId': 'OG000'}]}]}, {'title': 'Informity Programming', 'categories': [{'measurements': [{'value': '31.4', 'spread': '23.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 21 compared to baseline', 'description': "TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing.", 'unitOfMeasure': 'microjoule (μJ)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Clinician programmer electrode screening mode tool\n\nClinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '20.6', 'spread': '9.8', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '19.6', 'spread': '7.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 3 months compared to baseline', 'description': 'Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 3-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Clinician programmer electrode screening mode tool\n\nClinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '20.6', 'spread': '9.8', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '18.2', 'spread': '10.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 6 months compared to baseline', 'description': 'Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 6-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Clinician programmer electrode screening mode tool\n\nClinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process'}], 'classes': [{'title': 'Communication', 'categories': [{'measurements': [{'value': '7', 'spread': '13', 'groupId': 'OG000'}]}]}, {'title': 'Work / Finance', 'categories': [{'measurements': [{'value': '17', 'spread': '23', 'groupId': 'OG000'}]}]}, {'title': 'Hobbies / Leisure', 'categories': [{'measurements': [{'value': '35', 'spread': '35', 'groupId': 'OG000'}]}]}, {'title': 'Physical', 'categories': [{'measurements': [{'value': '36', 'spread': '22', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial', 'categories': [{'measurements': [{'value': '24', 'spread': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'Mean quality of life will be measured by the QUEST for ET subjects at baseline. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Clinician programmer electrode screening mode tool\n\nClinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process'}], 'classes': [{'title': 'Communication', 'categories': [{'measurements': [{'value': '19', 'spread': '11', 'groupId': 'OG000'}]}]}, {'title': 'Work / Finance', 'categories': [{'measurements': [{'value': '14', 'spread': '24', 'groupId': 'OG000'}]}]}, {'title': 'Hobbies / Leisure', 'categories': [{'measurements': [{'value': '25', 'spread': '31', 'groupId': 'OG000'}]}]}, {'title': 'Physical', 'categories': [{'measurements': [{'value': '28', 'spread': '20', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial', 'categories': [{'measurements': [{'value': '12', 'spread': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 3 months', 'description': 'Mean quality of life will be measured by the QUEST for ET subjects at 3 months follow-up visit. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Clinician programmer electrode screening mode tool\n\nClinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process'}], 'classes': [{'title': 'Communication', 'categories': [{'measurements': [{'value': '15', 'spread': '13', 'groupId': 'OG000'}]}]}, {'title': 'Work / Finance', 'categories': [{'measurements': [{'value': '5', 'spread': '14', 'groupId': 'OG000'}]}]}, {'title': 'Hobbies / Leisure', 'categories': [{'measurements': [{'value': '20', 'spread': '32', 'groupId': 'OG000'}]}]}, {'title': 'Physical', 'categories': [{'measurements': [{'value': '41', 'spread': '26', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial', 'categories': [{'measurements': [{'value': '13', 'spread': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 6 months', 'description': 'Mean quality of life will be measured by the QUEST for ET subjects at 6 months follow-up visit. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Mean Duration of Programming', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Clinician programmer electrode screening mode tool\n\nClinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process'}], 'classes': [{'title': 'Last programming session', 'categories': [{'measurements': [{'value': '76', 'spread': '70', 'groupId': 'OG000'}]}]}, {'title': 'Informity programming session', 'categories': [{'measurements': [{'value': '85', 'spread': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 21', 'description': 'Duration of programming at the Informity programming visit compared to the most recent programming session prior to enrollment', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Clinician programmer electrode screening mode tool\n\nClinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '44.8', 'spread': '32.7', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '75.1', 'spread': '70.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 3 months compared to baseline', 'description': 'Change in TEED at the 3-month follow-up visit compared to baseline', 'unitOfMeasure': 'milliampere (mA)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Change in Therapeutic Electrical Energy Delivered (TEED) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Clinician programmer electrode screening mode tool\n\nClinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '44.8', 'spread': '32.7', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '76.0', 'spread': '75.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 6 months compared to baseline', 'description': 'Change in TEED at the 6-month follow-up visit compared to baseline', 'unitOfMeasure': 'milliampere (mA)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm', 'description': 'Clinician programmer electrode screening mode tool\n\nClinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "The study enrolled a total of 8 subjects at 3 investigation sites. Of which seven subjects were diagnosed with Essential Tremor and one subject with Parkinson's Disease. The first subject enrollment was on June 26, 2019."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm', 'description': 'Clinician programmer electrode screening mode tool\n\nClinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64', 'spread': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Essential Tremor', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Parkinson's Disease", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Years of essential tremor symptoms', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '26', 'spread': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "Of the total 8 subjects enrolled, 7 subjects were diagnosed with Essential Tremor and 1 subject with Parkinson's Disease."}, {'title': 'Years since initial diagnosis of essential tremor', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "Of the total 8 subjects enrolled, 7 subjects were diagnosed with Essential Tremor and 1 subject with Parkinson's Disease."}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-08', 'size': 884104, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-29T00:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': "Outcomes assessor will be masked to subjects' deep brain stimulation programming."}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-28', 'studyFirstSubmitDate': '2018-12-18', 'resultsFirstSubmitDate': '2021-12-06', 'studyFirstSubmitQcDate': '2019-01-02', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-28', 'studyFirstPostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline', 'timeFrame': 'At Day 21 compared to baseline', 'description': "Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing."}, {'measure': 'Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit Compared to Baseline', 'timeFrame': 'At Day 21 compared to baseline', 'description': "Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing."}, {'measure': 'Change in Therapeutic Electrical Energy Delivered (TEED) With Selected Contact at the Informity Programming Visit Compared to Baseline', 'timeFrame': 'At Day 21 compared to baseline', 'description': "TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing."}, {'measure': 'Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to Baseline', 'timeFrame': 'At Day 21 compared to baseline', 'description': "TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing."}], 'secondaryOutcomes': [{'measure': 'Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 3 Months', 'timeFrame': 'At 3 months compared to baseline', 'description': 'Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 3-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.'}, {'measure': 'Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 6 Months', 'timeFrame': 'At 6 months compared to baseline', 'description': 'Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 6-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.'}, {'measure': 'Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline', 'timeFrame': 'At baseline', 'description': 'Mean quality of life will be measured by the QUEST for ET subjects at baseline. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.'}, {'measure': 'Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months', 'timeFrame': 'At 3 months', 'description': 'Mean quality of life will be measured by the QUEST for ET subjects at 3 months follow-up visit. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.'}, {'measure': 'Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months', 'timeFrame': 'At 6 months', 'description': 'Mean quality of life will be measured by the QUEST for ET subjects at 6 months follow-up visit. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.'}, {'measure': 'Mean Duration of Programming', 'timeFrame': 'At Day 21', 'description': 'Duration of programming at the Informity programming visit compared to the most recent programming session prior to enrollment'}, {'measure': 'Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months', 'timeFrame': 'At 3 months compared to baseline', 'description': 'Change in TEED at the 3-month follow-up visit compared to baseline'}, {'measure': 'Change in Therapeutic Electrical Energy Delivered (TEED) at 6 Months', 'timeFrame': 'At 6 months compared to baseline', 'description': 'Change in TEED at the 6-month follow-up visit compared to baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Essential Tremor', "Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "The objective of this clinical investigation is to characterize the clinical performance of Abbott's Clinician Programmer Electrode Screening Mode tool (InformityTM tool) in programming InfinityTM deep brain stimulation (DBS) systems for patients with Parkinson's disease (PD) or essential tremor (ET).", 'detailedDescription': "This is a prospective, non-randomized, single-arm, multi-center, post-market clinical investigation designed to evaluate Abbott's Informity tool for Infinity DBS systems.\n\nThis clinical investigation will be conducted at up to 5 centers in the United States.\n\nUp to 40 patients were intended to enroll in the study. However the study was stopped after enrolling 8 subjects at 3 sites.\n\nSubjects participating in this clinical investigation will be followed for 6 months. The expected duration of enrollment is 6 months. The total duration of the clinical investigation is expected to be 18 months. The primary and secondary endpoints will be evaluated when all subjects have completed their 6 month follow-up visits"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA\n\nParkinson's disease patients:\n\n1. Patient must provide written informed consent prior to any clinical study related procedure.\n2. Patient is 18 to 80 years of age.\n3. Patient is diagnosed with Parkinson's disease for at least 4 years according to standard practice.\n4. Patient is willing to maintain a constant dose of anti-Parkinson's disease medication indicated as best medical management for at least 1 month prior to study enrollment.\n5. Patient is willing and able to comply with the follow-up schedule for the length of the study.\n6. Patient has been implanted with an 8-channel directional Infinity deep brain stimulation system in the subthalamic nucleus (STN) within the last 12 months.\n7. Patient has had stable deep brain stimulation programming settings for at least 1 month prior to study enrollment.\n\nEssential tremor patients:\n\n1. Patient must provide written informed consent prior to any clinical study related procedure.\n2. Patient is 18 to 80 years of age.\n3. Patient is diagnosed with essential tremor for at least 4 years according to standard practice.\n4. Patient is willing to maintain a constant dose of anti-tremor medication indicated as best medical management for at least 1 month prior to study enrollment.\n5. Patient is willing and able to comply with the follow-up schedule for the length of the study.\n6. Patient has been implanted with an 8-channel directional Infinity deep brain stimulation system in the ventral intermediate (Vim) thalamus within the last 12 months.\n7. Patient has had stable deep brain stimulation programming settings for at least 1 month prior to study enrollment.\n\nEXCLUSION CRITERIA\n\n1. Individuals unable to make the decision to participate in a clinical investigation on their own.\n2. Patient is currently programmed with segmented electrodes, and cannot tolerate omnidirectional programming.\n3. Patient is being evaluated for a lead revision.\n4. Patient has untreated clinically significant depression.\n5. Patient has dementia that interferes with their ability to co-operate or comply with study requirements or comprehend the informed consent, as determined by the investigator.\n6. Patient abuses drugs or alcohol.\n7. Patient is currently enrolled or plans to enroll in another concurrent study that may confound the results of this clinical investigation.\n8. Patient has a confirmation of diagnosis of a terminal illness associated with survival \\<12 months.\n9. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the patient's ability to participate in the clinical study or to comply with follow-up requirements, or impact the scientific soundness of the clinical study results.\n10. Pregnant or nursing patients and those who plan pregnancy during the clinical study follow-up period."}, 'identificationModule': {'nctId': 'NCT03794661', 'acronym': 'EVIDENT', 'briefTitle': 'Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool', 'orgStudyIdInfo': {'id': 'ABT-CIP-10245'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'description': 'Clinician programmer electrode screening mode tool', 'interventionNames': ['Device: Clinician programmer electrode screening mode tool']}], 'interventions': [{'name': 'Clinician programmer electrode screening mode tool', 'type': 'DEVICE', 'otherNames': ['Informity tool'], 'description': 'Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Inland Northwest Research', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Bradley White', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott'}, {'name': 'Binith Cheeran', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Medical Devices Neuromodulation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}