Wearable electrical stimulation to improve balance after concussion
Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Vivonics, Inc. Industry-sponsored |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT07466589 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.