NCT05446194Completed
Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 1 Jul 2022
- Start date
- 12 Oct 2021
- Primary completion date
- 24 Jul 2025
- Lead sponsor
- University of Michigan
- Diseases
- Parkinson disease
- NCT number
- NCT05446194
What you commit to
- Study type: Interventional
- Participants enrolled: 72
- From 12 Oct 2021 to the primary completion date, 24 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Subjects limited by participation in research procedures involving ionizing radiation.
Other illness
- History of Meniere disease or recent onset of acute vestibular dysfunction, such as otolith disorders (BBPV etc).
- 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.
- Evidence of a stroke or mass lesion on structural brain imaging (MRI).
- Subjects with active and unstable mood or anxiety disorders
- Subjects with active ear infections or perforated eardrums
Other
- Severe claustrophobia precluding MR or PET imaging.
- Pregnancy (test within 48 hours of each PET session) or breastfeeding.
Who the study is looking for
- 1\. Parkinson disease duration of 5 years or more or Hoehn \& Yahr stage 1.5-4
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.