Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES)

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Vivonics, Inc.
Study ID
NCT07466589
Status
Recruiting
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Conditions

  • Mild Traumatic Brain Injury, Concussion

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Stochastic Galvanic Vestibular Stimulation (sGVS) — DEVICE
    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.

Study Details

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).

Key Dates

Start date
Aug 22, 2025
Status verified
Mar 2026
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: All Participants: Randomized Stimulation Sequence
    All participants complete all performance test types (TUG and mCTSIB + COBALT), and complete each performance test under all stimulation levels (Baseline + 0mA + 0.33mA + 0.67mA + 1.0mA). Test order and stimulation sequence are randomized.

Primary Outcome Measure

Change in Postural Sway during mCTSIB Across Stimulation Conditions [ Time Frame: Performance assessed when VIPES is worn and patient is completing the testing procedure. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan, Michigan MedicineAnn ArborMichigan48109
Deb Demski, MUP, MSW, CCRP
[email protected]
734-647-2147
Matthew Morley, MA
[email protected]
734-647-3326
Devin L McCaslin, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan, Michigan Medicine· Ann Arbor, MI

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