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.
Basic testing of participants began in November 2021, but using the device or sham will not begin prior to July 2022.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
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.
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.
University of Michigan
Ann Arbor, Michigan, United States
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
Time frame: after a week of treatment
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