Investigating balance issues in Parkinson's disease using inner ear stimulation
Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease
This study is testing if using a special device to stimulate the inner ear can help people with Parkinson's disease improve their balance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05446194 on ClinicalTrials.gov |
What this trial studies
This study explores the relationship between vestibular dysfunction and balance problems in individuals with Parkinson's disease. It aims to determine if stimulating the inner ear with a non-invasive device can improve balance in patients. The research includes clinical testing, brain imaging, and the application of an interventional treatment device. Basic testing began in November 2021, with the device intervention set to start in July 2022.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Parkinson's disease for at least 5 years, who are at Hoehn & Yahr stages 1.5 to 4.
Not a fit: Patients with atypical parkinsonism or recent vestibular dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved balance and reduced fall risk for patients with Parkinson's disease.
How similar studies have performed: While the approach is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Parkinson disease duration of 5 years or more or Hoehn \& Yahr stage 1.5-4 Exclusion Criteria: 1. History of Meniere disease or recent onset of acute vestibular dysfunction, such as otolith disorders (BBPV etc). 2. 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. 3. Evidence of a stroke or mass lesion on structural brain imaging (MRI). 4. 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. 5. Severe claustrophobia precluding MR or PET imaging. 6. Subjects limited by participation in research procedures involving ionizing radiation. 7. Pregnancy (test within 48 hours of each PET session) or breastfeeding. 8. Subjects with active and unstable mood or anxiety disorders 9. Subjects with active ear infections or perforated eardrums
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Chatkaew Pongmala, PhD — University of Michigan
- Study coordinator: Jaimie Barr, BSc
- Email: jaimieba@med.umich.edu
- Phone: 734-998-6894
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.