Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Device: Non invasive neuromodulation device pattern 2; Device: Non invasive neuromodulation device pattern 1

• Registration Number: NCT05446194
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2021-10-12
• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-01
• Study First Posted: 2022-07-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational Treatment 2	Non invasive neuromodulation device pattern 2	Investigational treatment stimulation pattern 2
Investigational Treatment 1	Non invasive neuromodulation device pattern 1	Investigational treatment stimulation pattern 1

Primary Outcome Measures

Name	Time	Method
Freezing of Gait	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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States