Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT05446194
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2022-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2022-07-01', 'studyFirstSubmitQcDate': '2022-07-01', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freezing of Gait', 'timeFrame': 'after a week of treatment', 'description': 'Freezing of Gait is measured by the New Freezing of Gate Questionnaire, the current gold standard for assessment of FoG in Parkinsons Disease. Measured on a scale of 0 - 28 points with higher numbers representing more severe freezing of gait'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'This study investigates whether vestibular (inner ear) dysfunction is a cause for poor balance in Parkinson Disease (PD), and whether inner ear stimulation with a small device may improve balance. This study will involve clinical testing, brain imaging, and an interventional treatment device for symptoms.', 'detailedDescription': 'Basic testing of participants began in November 2021, but using the device or sham will not begin prior to July 2022.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Parkinson disease duration of 5 years or more or Hoehn \\& Yahr stage 1.5-4\n\nExclusion Criteria:\n\n1. History of Meniere disease or recent onset of acute vestibular dysfunction, such as otolith disorders (BBPV etc).\n2. Other disorders which may resemble PD, such as progressive supranuclear palsy (PSP), vascular dementia, normal pressure hydrocephalus, multiple system atrophy (MSA), corticobasal ganglionic degeneration, or toxic causes of parkinsonism. Prototypical cases have distinctive clinical profiles, like early and severe dysautonomia (MSA) or appendicular apraxia, which may differentiate them from idiopathic PD and PSP. The use of the UKPDSBRC clinical diagnostic criteria for PD will mitigate the inclusion of subjects with atypical parkinsonism.\n3. Evidence of a stroke or mass lesion on structural brain imaging (MRI).\n4. Participants in whom MRI is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.\n5. Severe claustrophobia precluding MR or PET imaging.\n6. Subjects limited by participation in research procedures involving ionizing radiation.\n7. Pregnancy (test within 48 hours of each PET session) or breastfeeding.\n8. Subjects with active and unstable mood or anxiety disorders\n9. Subjects with active ear infections or perforated eardrums'}, 'identificationModule': {'nctId': 'NCT05446194', 'acronym': 'VEST', 'briefTitle': 'Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease', 'orgStudyIdInfo': {'id': 'HUM00192613'}, 'secondaryIdInfos': [{'id': 'I01 RX003397 1-01A1', 'type': 'OTHER_GRANT', 'domain': 'US Department of Veterans Affairs'}, {'id': 'I01RX003397', 'link': 'https://reporter.nih.gov/quickSearch/I01RX003397', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational Treatment 1', 'description': 'Investigational treatment stimulation pattern 1', 'interventionNames': ['Device: Non invasive neuromodulation device pattern 1']}, {'type': 'EXPERIMENTAL', 'label': 'Investigational Treatment 2', 'description': 'Investigational treatment stimulation pattern 2', 'interventionNames': ['Device: Non invasive neuromodulation device pattern 2']}], 'interventions': [{'name': 'Non invasive neuromodulation device pattern 1', 'type': 'DEVICE', 'description': 'The study device consists of a headset, which looks like a music earphone headset, and a base station that powers the headset. The headset has metallic earpieces that fit into the ear canals. When activated, the study device will deliver a prescribed stimulation pattern for approximately 20 minutes.', 'armGroupLabels': ['Investigational Treatment 1']}, {'name': 'Non invasive neuromodulation device pattern 2', 'type': 'DEVICE', 'description': 'The study device consists of a headset, which looks like a music earphone headset, and a base station that powers the headset. The headset has metallic earpieces that fit into the ear canals. When activated, the study device will deliver a prescribed stimulation pattern for approximately 20 minutes.', 'armGroupLabels': ['Investigational Treatment 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Chatkaew Pongmala, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Per the informed consent, which allows for opt-out of data sharing, some of the observational research data and brain images collected in this study (collectively referred to as "research data") may be shared with University of Michigan investigators, investigators from outside of the University of Michigan, or may be submitted to data repositories with permission from the participant. Representatives of the Study Device Sponsor may have access to participant data but will not share it.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Investigator', 'investigatorFullName': 'Chatkaew Pongmala', 'investigatorAffiliation': 'University of Michigan'}}}}