NCT05446194

Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Non invasive neuromodulation device pattern 1	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.
DEVICE	Non invasive neuromodulation device pattern 2	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.

Timeline

• Start date: 2021-10-12
• Primary completion: 2025-07-24
• Completion: 2025-07-24
• First posted: 2022-07-06
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study