Vestibulopathy, Imbalance and Gait Disturbances in Parkinson Disease
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 whether imbalance and gait problems in people with Parkinson's disease may be related to vestibular (inner ear balance center) changes not related to loss of dopamine in the brain.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:
• 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.
Locations
United States
Michigan
University of Michigan
NOT_YET_RECRUITING
Ann Arbor
VA Ann Arbor Healthcare System, Ann Arbor, MI
RECRUITING
Ann Arbor
Contact Information
Primary
Nicolaas I Bohnen, MD PhD
nicolaas.bohnen@va.gov
(734) 769-7100
Time Frame
Start Date: 2021-05-28
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 64
Treatments
No_intervention: Main cohort
Main cohort of all patients
Sham_comparator: Subgroup of patients with imbalance
Subgroup of patients with imbalance
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development
Collaborators: US Department of Veterans Affairs