Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES)

NCT07466589 | Recruiting

• 2 other identifiers: HUM00257686HT942524C0022
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change in Postural Sway during mCTSIB Across Stimulation Conditions

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

  Performance assessed when VIPES is worn and patient is completing the testing procedure.

• Change in TUG Time to Completion

  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).

  Performance assessed when VIPES is worn and patient is completing the testing procedure.

• Change in Postural Sway during COBALT

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

  Performance assessed when VIPES is worn and patient is completing the testing procedures

Study Arms (1)

All Participants: Randomized Stimulation Sequence

EXPERIMENTAL

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.

Device: Stochastic Galvanic Vestibular Stimulation (sGVS)

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.

All Participants: Randomized Stimulation Sequence

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vivonics, Inc.: lead
• University of Michigan: collaborator

Study Sites (1)

University of Michigan, Michigan Medicine

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Devin L McCaslin, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Colls, B.S.

CONTACT

781-373-1930; jcolls@vivonics.com

Deb Demski, MUP, MSW, CCRP

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Although this is a single-arm, within-subject crossover study, participants are not informed of the stimulation level (sham vs. active) applied during each test. Stimulation levels (0mA sham, 0.33mA, 0.67mA, 1.0mA) are randomized and applied silently without cue or display. The participants cannot distinguish the stimulation level during testing. Therefore, participant masking is maintained.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study uses a within-subject, crossover assignment model in which all participants experience every condition. Each subject completes testing procedures at randomized stimulation levels during testing. The subjects will complete the testing procedures TUG, mCTSIB, and COBALT, at at four randomized stimulation levels: 0mA (SHAM), 0.33mA, 0.67mA, and 1.0mA. Given this study is a repeated measures study, each subject will complete a trial of a given testing procedure at a certain stimulation level twice, and continue to do so for all other testing procedures and stimulation levels. The design allows for within-subject comparisons to randomized sham controls, across stimulation intensities in effort to enhancing sensitivity in detecting changes in performance.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: March 12, 2026
• Study Start: August 22, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)