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:
University of Michigan
Organization:
Study Overview
Official Title:
Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VEST
Brief Summary:
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.
Detailed Description:
Basic testing of participants began in November 2021, but using the device or sham will not begin prior to July 2022.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| I01 RX003397 1-01A1 | OTHER_GRANT | US Department of Veterans Affairs | View | |
| I01RX003397 | NIH | None | https://reporter.nih.gov/quic… | View |