Study of Portable Electrical Stimulation to Improve Balance in Adults With Mild Traumatic Brain Injury and Concussion

What this Trial Is About

Researchers are evaluating the potential benefits of stochastic galvanic vestibular stimulation sGVS in improving balance, gait, and overall vestibular function for people who have balance problems due to mild traumatic brain injury mTBI or concussion. This study involves a wearable device called the VIPES system, which delivers low-frequency electrical stimulation aimed at enhancing vestibular system function affected by mTBI. The investigation is a single-arm study with 32 participants, designed to assess if this stimulation can improve performance on clinical balance and mobility tests. Participants will use the VIPES device, which includes four electrodes placed behind the ears and delivers random electrical stimulation at various levels 0mA sham, 0.33mA, 0.67mA, and 1.0mA during testing. Each participant completes several balance and mobility tests, including the Modified Clinical Test of Sensory Integration on Balance mCTSIB, the COBALT balance test, and the Timed Up and Go TUG test. Tests are performed under different stimulation conditions with randomized order, and participants do not know the stimulation level during trials. During the study visit, participants provide demographic and medical history information, complete symptom questionnaires, and undergo height and weight measurements. They perform all balance and mobility tests under each stimulation level, with breaks between tests. The study collects data on postural sway and TUG completion time to measure performance changes. After testing, participants fill out a usability questionnaire. The entire visit lasts about two hours. The results will help determine if electrical stimulation improves balance and guide future studies.

Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES)