Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease

NCT ID: NCT05446194

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2025-07-24

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.

Detailed Description

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

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Investigational Treatment 1

Investigational treatment stimulation pattern 1

Group Type: EXPERIMENTAL

Non invasive neuromodulation device pattern 1

Intervention Type: 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

Investigational treatment stimulation pattern 2

Group Type: EXPERIMENTAL

Non invasive neuromodulation device pattern 2

Intervention Type: 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.

Interventions

Non invasive neuromodulation device pattern 1

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.

Intervention Type: DEVICE

Non invasive neuromodulation device pattern 2

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

8. Subjects with active and unstable mood or anxiety disorders

9. Subjects with active ear infections or perforated eardrums

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Chatkaew Pongmala

Research Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chatkaew Pongmala, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

I01 RX003397 1-01A1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

I01RX003397

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00192613

Identifier Type: -

Identifier Source: org_study_id