Status:
COMPLETED
Vestibulopathy as a Cause of Imbalance in Parkinson
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
US Department of Veterans Affairs
Conditions:
Parkinson's Disease
Eligibility:
All Genders
45+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 whethe...
Detailed Description
Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by resting tremor, slowness of movement, rigidity as well as postural instability and gait difficulties (PIGD) motor ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04768647
Start Date
May 28 2021
End Date
October 30 2025
Last Update
November 25 2025
Active Locations (2)
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1
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105-2303
2
University of Michigan
Ann Arbor, Michigan, United States, 48105