Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorVivonics, Inc.
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-55
Diagnosed with concussion, evaluated at the University of Michigan
Symptoms persistent greater than 4-6 weeks
Self-reported imbalance
Disqualifiers
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).
Trial design
Design model
Crossover
Treatments tested in this trial
Stochastic Galvanic Vestibular Stimulation (sGVS)
DeviceThe 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.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: All Participants: Randomized Stimulation SequenceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Performance assessed when VIPES is worn and patient is completing the testing procedure.2
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).
Time frame
Performance assessed when VIPES is worn and patient is completing the testing procedure.3
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).
Time frame
Performance assessed when VIPES is worn and patient is completing the testing proceduresSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vivonics, Inc.
Lead sponsor
University of Michigan
Collaborator
Source ClinicalTrials.gov