Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease

Trial ID: NCT05446194

Interventional - Phase Unknown - Completed

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.

Conditions

• Parkinson Disease

Interventions

• Non invasive neuromodulation device pattern 1
• Non invasive neuromodulation device pattern 2

Eligibility

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

Sponsor

University of Michigan, US Department of Veterans Affairs

Source: ClinicalTrials.gov

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