Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES)
NCT07466589 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2026-03-12
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).
Conditions
- Mild Traumatic Brain Injury, Concussion
Interventions
- DEVICE
-
Stochastic 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.
Sponsors & Collaborators
- collaborator OTHER
-
Vivonics, Inc.
lead INDUSTRY
Principal Investigators
-
Devin L McCaslin, PhD · University of Michigan
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-22
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
Countries
- United States
Study Locations
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