NCT04768647CompletedPhase 1/2
Vestibulopathy as a Cause of Imbalance in Parkinson
Vestibulopathy, Imbalance and Gait Disturbances in Parkinson Disease
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
Balance problems and falls are common in people with Parkinson's disease but respond poorly to dopamine stimulating medications suggesting other causes. The main goal of this study is to assess whether imbalance and gait problems in people with Parkinson's disease may be related to vestibular (inner ear balance center) changes not related to loss of dopamine in the brain.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 19 Feb 2021
- Start date
- 28 May 2021
- Primary completion date
- 30 Oct 2025
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Parkinson disease
- NCT number
- NCT04768647
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 60
- From 28 May 2021 to the primary completion date, 30 Oct 2025
- 2 sites 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).
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
- PD based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Research Criteria (n=64, gross recruitment)
- M/F
- age 45 years or older
- duration of disease \> 5 years and/or Hoehn \& Yahr stages 1.5-4 able to ambulate independently and no evidence of dementia.
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown 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.