RecruitingNot ApplicableNCT07466589

Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES)


Sponsor

Vivonics, Inc.

Enrollment

32 participants

Start Date

Aug 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal is to assess the potential benefit of stochastic galvanic vestibular stimulation (sGVS) in improving patient performance with respect to balance, gait, and/or overall vestibular function for individuals with known deficits in vestibular performance as a result of a mild traumatic brain injury (mTBI).


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria6

  • Age 18-55
  • Diagnosed with concussion, evaluated at the University of Michigan
  • Symptoms persistent greater than 4-6 weeks
  • Self-reported imbalance
  • 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 Criteria4

  • Anyone under the age of 18 or over the age of 55
  • Presence of prior diagnosis of peripheral vestibulopathy
  • Women who are pregnant
  • Inability to complete testing (e.g., severe symptom burden, inability to stand unassisted).

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Interventions

DEVICEStochastic Galvanic Vestibular Stimulation (sGVS)

The investigational intervention is a non-invasive, wearable vestibular stimulation system that delivers subsensory electrical stimulation via surface electrodes behind the ears. Stimulation is delivered at one of four levels (0.33mA, 0.67mA, 1.0mA, and 0mA sham) during standard clinical balance and mobility assessments (TUG and BERTEC). Participants are blinded to stimulation level during each trial.


Locations(1)

University of Michigan, Michigan Medicine

Ann Arbor, Michigan, United States

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NCT07466589


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