Wearable electrical stimulation to improve balance after concussion
Official title: Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES)
Run by Vivonics, Inc. · NCT07466589 · Data updated 2026-11-12
This will test a small wearable device that gives gentle, random electrical stimulation behind the ears to see if it improves balance and walking in adults who still have symptoms after a concussion.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Vivonics, Inc. Industry-sponsored |
| Locations | 1 site (Ann Arbor, Michigan) |
| Status | Recruiting |
| Started | August 22, 2025 |
| Main results expected | March 2026 |
| Study ends | March 2026 |
| Registry record updated | March 12, 2026 |
| Trial ID | NCT07466589 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking adults aged 18–55 with a University of Michigan–diagnosed concussion, persistent symptoms for more than 4–6 weeks, self-reported imbalance, and the ability to attend an in-person testing session.
✕Probably not a fit
Patients with prior peripheral vestibular disorders, those outside the 18–55 age range, pregnant women, or people unable to safely stand for testing are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-arm, within-subject crossover study enrolls 32 adults with persistent balance problems after mild traumatic brain injury. Participants complete baseline balance and mobility tests (Timed Up and Go, mCTSIB + COBALT) while wearing the VIPES device and then repeat tests under four randomized stimulation levels including a 0 mA sham. The VIPES wearable delivers stochastic galvanic vestibular stimulation (low-frequency random noise 0–5 Hz) via four electrodes behind the ears, and participants are blinded to stimulation level. Clinical performance is measured with Bertec dual-balance plates and APDM Opal sensors to determine whether specific stimulation amplitudes acutely improve balance and gait.
Why it matters
Potential benefit: If successful, this approach could offer a portable, non-invasive way to reduce imbalance and improve walking function after concussion.
How similar studies have gone: Small prior studies of stochastic galvanic vestibular stimulation have produced modest balance improvements in other populations, but its effectiveness specifically for post-concussion vestibular deficits remains experimental.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-55 2. Diagnosed with concussion, evaluated at the University of Michigan 3. Symptoms persistent greater than 4-6 weeks 4. Self-reported imbalance 5. Must be able to attend in-person session. No racial/ethnic groups will be excluded, although all participants must be fluent speakers of English. Exclusion Criteria: 1. Anyone under the age of 18 or over the age of 55 2. Presence of prior diagnosis of peripheral vestibulopathy 3. Women who are pregnant 4. Inability to complete testing (e.g., severe symptom burden, inability to stand unassisted).
Where it's running
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University of Michigan, Michigan Medicine
Ann Arbor, Michigan, United States Recruiting
Study contacts
- Principal investigator: Devin L McCaslin, PhD — University of Michigan
- Study coordinator: Joshua Colls, B.S.
- Email: jcolls@vivonics.com
- Phone: 781-373-1930
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.