Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES) for Mild Traumatic Brain Injury

This study is testing a wearable device called VIPES (Vestibular Intervention Via Portable Electrical Stimulator) for people who have ongoing balance issues after a mild traumatic brain injury (mTBI) or concussion. The VIPES device delivers a very low level of electrical stimulation behind the ears, which you shouldn't be able to feel. Researchers want to see if this stimulation can improve your balance and walking. To join, you must be 18-55 years old, have a concussion diagnosed at the University of Michigan with symptoms lasting over 4-6 weeks, and report feeling imbalanced. The study will measure improvements in your balance and walking speed while you are wearing the VIPES device. The current recruitment status is unclear.

Study design
This is a single-arm study, meaning all 32 participants will receive the investigational intervention. It is designed as a within-subject crossover study, where each participant will experience different stimulation levels.
What's involved
You will attend in-person sessions where you will complete balance and mobility tests (like the Timed Up and Go) under different stimulation levels from the VIPES device.
Compensation
Not stated in the trial record.
Follow-up
Performance is assessed only when the VIPES device is worn and you are completing the testing procedure; no long-term follow-up is specified.

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NCT07466589

Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES)

Recruiting
NAAges 18–55InterventionalTreatment
Vivonics, Inc.
~32 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:Stochastic Galvanic Vestibular Stimulation (sGVS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Postural Sway during mCTSIB Across Stimulation Conditions
Measured over Performance assessed when VIPES is worn and patient is completing the testing procedure.
+2 more outcomes measured
Mild Traumatic Brain Injury, Concussion
1 sites across 1 states
Michigan1
  • Devin L McCaslin, PhD · PRINCIPAL_INVESTIGATOR · University of Michigan

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  • Change in Postural Sway during mCTSIB Across Stimulation ConditionsPerformance assessed when VIPES is worn and patient is completing the testing procedure.

    Comparison of sway area (deg/s) during mCTSIB at stimulation conditions (0.33mA, 0.67mA, and 1mA) in comparison to randomized Sham (0mA).

  • Change in TUG Time to CompletionPerformance assessed when VIPES is worn and patient is completing the testing procedure.

    Comparison of time to complete the Timed Up and Go (TUG) test (seconds) at stimulation conditions (0.33mA, 0.67mA, and 1mA) in comparison to randomized Sham (0mA).

  • Change in Postural Sway during COBALTPerformance assessed when VIPES is worn and patient is completing the testing procedures

    Comparison of sway area (deg/s) during COBALT at stimulation conditions (0.33mA, 0.67mA, and 1mA) in comparison to randomized Sham (0mA).