Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease (VEST)

University of Michigan

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Non invasive neuromodulation device pattern 2; Device: Non invasive neuromodulation device pattern 1

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05446194

I01RX003397 (U.S. NIH Grant/Contract)

HUM00192613

I01 RX003397 1-01A1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 72 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

Investigational Treatment 1

Experimental group

Description:

Investigational treatment stimulation pattern 1

Treatment:

Device: Non invasive neuromodulation device pattern 1

Investigational Treatment 2

Experimental group

Description:

Investigational treatment stimulation pattern 2

Treatment:

Device: Non invasive neuromodulation device pattern 2