An interventional study of Non invasive neuromodulation device pattern 1 and Non invasive neuromodulation device pattern 2 in Parkinson Disease, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 72 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
1. Parkinson disease duration of 5 years or more or Hoehn \& Yahr stage 1.5-4
Exclusion Criteria:
Investigational treatment stimulation pattern 1
Device: Non invasive neuromodulation device pattern 1
Investigational treatment stimulation pattern 2
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.
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.
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Per the informed consent, which allows for opt-out of data sharing, some of the observational research data and brain images collected in this study (collectively referred to as "research data") may be shared with University of Michigan investigators, investigators from outside of the University of Michigan, or may be submitted to data repositories with permission from the participant. Representatives of the Study Device Sponsor may have access to participant data but will not share it.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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