RECRUITING

Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease

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Conditions

Parkinson Disease

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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

This study investigates whether vestibular (inner ear) dysfunction is a cause for poor balance in Parkinson Disease (PD), and whether inner ear stimulation with a small device may improve balance. This study will involve clinical testing, brain imaging, and an interventional treatment device for symptoms.

Official Title

Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease

Quick Facts

Study Start:2021-10-12
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05446194

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. 1. Parkinson disease duration of 5 years or more or Hoehn \& Yahr stage 1.5-4
  1. 1. History of Meniere disease or recent onset of acute vestibular dysfunction, such as otolith disorders (BBPV etc).
  2. 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. 3. Evidence of a stroke or mass lesion on structural brain imaging (MRI).
  4. 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. 5. Severe claustrophobia precluding MR or PET imaging.
  6. 6. Subjects limited by participation in research procedures involving ionizing radiation.
  7. 7. Pregnancy (test within 48 hours of each PET session) or breastfeeding.
  8. 8. Subjects with active and unstable mood or anxiety disorders
  9. 9. Subjects with active ear infections or perforated eardrums

Contacts and Locations

Study Contact

Jaimie Barr, BSc
CONTACT
734-998-6894
jaimieba@med.umich.edu

Principal Investigator

Chatkaew Pongmala, PhD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48106
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Chatkaew Pongmala, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

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 Date2021-10-12
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2021-10-12
Study Completion Date2025-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Parkinson Disease