Vestibulopathy as a Cause of Imbalance in Parkinson

NCT04768647 | Completed Phase 1 FDA Device

• 2 other identifiers: N3397-R1I01RX003397
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

dopamine; imbalance; vestibular

Outcome Measures

Primary Outcomes (2)

• Vestibular function

  Assessment of vestibular functions using standard vestibular testing

  through study completion, an average of 4 weeks

• Imbalance score

  Clinical imbalance motor score

  through study completion, an average of 1 year

Secondary Outcomes (1)

• DAT brain PET

  through study completion, an average of 1 year

Study Arms (2)

Main cohort

NO INTERVENTION

Main cohort of all patients

Subgroup of patients with imbalance

SHAM COMPARATOR

Subgroup of patients with imbalance

Device: TNM

Interventions

TNM DEVICE

TNM is a small portable head set that can be used by the participants at home to stimulate the vestibular system

Also known as: Thermoneuromodulation

Subgroup of patients with imbalance

Eligibility Criteria

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

You may qualify if:

• PD based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Research Criteria (n=64, gross recruitment)
• M/F
• age 45 years or older
• duration of disease \> 5 years and/or Hoehn \& Yahr stages 1.5-4 able to ambulate independently and no evidence of dementia.

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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• US Department of Veterans Affairs: collaborator

Study Sites (2)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

University of Michigan

Ann Arbor, Michigan, 48105, 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

• Nicolaas I Bohnen, MD PhD

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Independent assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is an observational study where a subset of eligible and interested participants can participate in a biomechanistic pilot device study.

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 24, 2021
• Study Start: May 28, 2021
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)