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OpenTrials
Completed

NCT Number: NCT05446194

Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48106, United States

About this study

Basic testing of participants began in November 2021, but using the device or sham will not begin prior to July 2022.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parkinson disease duration of 5 years or more or Hoehn & Yahr stage 1.5-4

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.
  • Subjects with active and unstable mood or anxiety disorders
  • Subjects with active ear infections or perforated eardrums

Treatment and study plan

Non invasive neuromodulation device pattern 1

Device

The study device consists of a headset, which looks like a music earphone headset, and a base station that powers the headset. The headset has metallic earpieces that fit into the ear canals. When activated, the study device will deliver a prescribed stimulation pattern for approximately 20 minutes.

Non invasive neuromodulation device pattern 2

Device

The study device consists of a headset, which looks like a music earphone headset, and a base station that powers the headset. The headset has metallic earpieces that fit into the ear canals. When activated, the study device will deliver a prescribed stimulation pattern for approximately 20 minutes.

Primary outcomes

  1. Freezing of Gait

    Time frame: after a week of treatment

    Freezing of Gait is measured by the New Freezing of Gate Questionnaire, the current gold standard for assessment of FoG in Parkinsons Disease. Measured on a scale of 0 - 28 points with higher numbers representing more severe freezing of gait

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • US Department of Veterans Affairs

Registry information

Acronym: VEST

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 6, 2022
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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