Recruiting

sGVS

Sponsor:

Vivonics, Inc.

Code:

NCT07466589

Conditions

Mild Traumatic Brain Injury, Concussion

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Stochastic Galvanic Vestibular Stimulation (sGVS)

Study Details

Brief 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

Study ID

NCT07466589

Start date

Aug 22, 2025

Status verified date

Mar, 2026

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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. ]
  • Change in TUG Time to Completion [ Time Frame: Performance assessed when VIPES is worn and patient is completing the testing procedure. ]
  • Change in Postural Sway during COBALT [ Time Frame: Performance assessed when VIPES is worn and patient is completing the testing procedures ]

Central Contacts and Locations

Central contacts

Joshua Colls, B.S.

781-373-1930jcolls@vivonics.com

Deb Demski, MUP, MSW, CCRP

734-647-2147darfy@med.umich.edu

Locations

University of Michigan, Michigan Medicine

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Deb Demski, MUP, MSW, CCRP

734-647-2147darfy@med.umich.edu

Matthew Morley, MA

734-647-3326morleymm@umich.edu

Principal Investigator:

Devin L McCaslin, PhD

More Information

Sponsor

Vivonics, Inc.

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

  • mTBI
  • mild traumatic brain injury
  • concussion
  • balance
  • gait
  • vestibular
  • GVS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vivonics, Inc. on 2026-03-12.