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Vestibulopathy as a Cause of Imbalance in Parkinson

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Conditions

Parkinson's Diseasedopamineimbalancevestibular

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Vestibulopathy, Imbalance and Gait Disturbances in Parkinson Disease

Quick Facts

Study Start:2021-05-28
Study Completion:2025-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04768647

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * PD based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Research Criteria (n=64, gross recruitment)
  2. * M/F
  3. * age 45 years or older
  4. * duration of disease \> 5 years and/or Hoehn \& Yahr stages 1.5-4 able to ambulate independently and no evidence of dementia.
  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.

Contacts and Locations

Principal Investigator

Nicolaas I Bohnen, MD PhD
PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Locations (Sites)

VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
United States
University of Michigan
Ann Arbor, Michigan, 48105
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Nicolaas I Bohnen, MD PhD, PRINCIPAL_INVESTIGATOR, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-28
Study Completion Date2025-10-30

Study Record Updates

Study Start Date2021-05-28
Study Completion Date2025-10-30

Terms related to this study

Keywords Provided by Researchers

  • dopamine
  • imbalance
  • vestibular

Additional Relevant MeSH Terms

  • Parkinson's Disease