Investigating balance issues in Parkinson's disease related to inner ear changes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.