Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease

NCT05446194 | Completed DMC FDA Device

• 3 other identifiers: HUM00192613I01 RX003397 1-01A1I01RX003397
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Freezing of Gait

  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

  after a week of treatment

Study Arms (2)

Investigational Treatment 1

EXPERIMENTAL

Investigational treatment stimulation pattern 1

Device: Non invasive neuromodulation device pattern 1

Investigational Treatment 2

EXPERIMENTAL

Investigational treatment stimulation pattern 2

Device: Non invasive neuromodulation device pattern 2

Interventions

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.

Investigational Treatment 1

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.

Investigational Treatment 2

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of Meniere disease or recent onset of acute vestibular dysfunction, such as otolith disorders (BBPV etc).
• 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

Sponsors & Collaborators

• University of Michigan: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Chatkaew Pongmala, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Investigator

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 6, 2022
• Study Start: October 12, 2021
• Primary Completion: July 24, 2025
• Study Completion: July 24, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)