Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease
Completed · Not applicable
Conditions studied: Parkinson Disease
In brief
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.
Key facts
- Study ID
- NCT05446194
- Run by
- University of Michigan
- People needed
- 72
- Starts
- 2021-10-12
- Expected to finish
- 2025-07-24
- Last updated by the study team
- 2026-02-17
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Parkinson disease duration of 5 years or more or Hoehn \& Yahr stage 1.5-4
You may not qualify if…
- 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).
- 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.
- Severe claustrophobia precluding MR or PET imaging.
- Subjects limited by participation in research procedures involving ionizing radiation.
- Pregnancy (test within 48 hours of each PET session) or breastfeeding.
- Subjects with active and unstable mood or anxiety disorders
- Subjects with active ear infections or perforated eardrums
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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