Investigating balance issues in Parkinson's disease related to inner ear changes
Vestibulopathy, Imbalance and Gait Disturbances in Parkinson Disease
This study is testing how changes in the inner ear might affect balance problems in people with Parkinson's disease to see if a new treatment can help them feel more stable.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Drugs / interventions | radiation |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Trial ID | NCT04768647 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the relationship between vestibular changes and balance problems in individuals with Parkinson's disease. It focuses on understanding how chronic vestibulopathy may contribute to postural instability and gait difficulties, which are often resistant to traditional dopamine treatments. The research will involve dedicated assessment methods to confirm preliminary findings and evaluate the potential benefits of vestibular stimulation as a therapeutic approach. By addressing this knowledge gap, the study seeks to improve the management of balance issues in Parkinson's patients.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Parkinson's disease for more than five years, aged 45 or older, who can ambulate independently.
Not a fit: Patients with acute vestibular dysfunction or atypical parkinsonism disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for improving balance and reducing falls in patients with Parkinson's disease.
How similar studies have performed: Preliminary data suggests that vestibulopathy may play a significant role in balance issues for Parkinson's patients, but this specific approach is still being validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Ann Arbor, Michigan and 1 other locations
- VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Nicolaas I Bohnen, MD PhD — VA Ann Arbor Healthcare System, Ann Arbor, MI
- Study coordinator: Nicolaas I Bohnen, MD PhD
- Email: nicolaas.bohnen@va.gov
- Phone: (734) 769-7100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.