Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES)
Vivonics, Inc.
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).
Description
The VIPES system that delivers sGVS is a small wearable device that administers stimulation aiming to improve the function of a vestibular system that has been adversely affected by mild TBI, concussion. In particular VIPES is designed to provide stimulus comprising random noise in a low frequency band (0 to 5Hz maximum) below the level of perception by the subject. The VIPES system consists of the four electrodes (two behind each ear). The stimulator can deliver the stimulation in multiple directions and receive information about the amplitude delivered accounting for skin impedance. The Bert…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
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).
Interventions
- DeviceStochastic 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.
Location
- University of Michigan, Michigan MedicineAnn Arbor, Michigan