RECRUITINGINTERVENTIONAL
Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES)
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
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).
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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).
Treatments Being Tested
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.
Locations (1)
University of Michigan, Michigan Medicine
Ann Arbor, Michigan, United States