Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease

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

Official Title
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Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Non invasive neuromodulation device pattern 1
* Device: Non invasive neuromodulation device pattern 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Parkinson disease duration of 5 years or more or Hoehn & Yahr stage 1.5-4 Exclusion Criteria: History of Meniere disease or recent onset of acute vestibular dysfunction, such as otolith disorders (BBPV etc). 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. 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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Treatment 1<br>Investigational treatment stimulation pattern 1 | Device: Non invasive neuromodulation device pattern 1<br>* 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.<br>|
| Experimental: Investigational Treatment 2<br>Investigational treatment stimulation pattern 2 | Device: Non invasive neuromodulation device pattern 2<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |