Vestibular Intervention Via Portable Electrical Stimulator (VIPES)

Study Overview
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Brief Summary
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The purpose of this study is to develop a vestibular interventional approach using stochastic vestibular stimulation (SVS) through a small, lightweight device, and a comfortable electrode set on the back of the head that stimulates the vestibular system and produces immediate improvements in balance, gait, and overall vestibular function for patients will balance disorder.

Official Title
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Vestibular Intervention Via Portable Electrical Stimulator (VIPES)

Conditions
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Balance Disorder

Intervention / Treatment
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* Device: Vestibular Intervention via Portable Electrical Stimulator (VIPES) system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be able to consent to participate themselves. Participants must be 21 to 55 years of age. Must be able to attend in-person sessions at the Mayo Aerospace Medicine and - Vestibular Research Laboratory in Scottsdale, AZ. No racial/ethnic groups will be excluded. All participants must be fluent speakers of English. Exclusion Criteria: Presence of peripheral vestibulopathy (cleared by Dix-Hallpike, vHIT as part of clinical evaluation). Women who are pregnant. Inability to complete testing (e.g., severe symptom burden, inability to stand unassisted).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stochastic Vestibular Stimulation (SVS) Condition<br>Subjects will perform standard clinical testing for balance and gait while wearing the Vestibular Intervention via Portable Electrical Stimulator (VIPES) system. The SVS device will be active throughout the testing at the respective current levels (i.e., 0.2mA to 1 mA at 0.2 mA increments). | Device: Vestibular Intervention via Portable Electrical Stimulator (VIPES) system<br>* A small, lightweight device able to deliver stochastic vestibular stimulation (SVS) using a comfortable electrode set on the back of the head as well as other proven modes of galvanic vestibular stimulation (GVS) related vestibular correction when required to mitigate motion sickness or provide auxiliary vestibular cueing.<br>|
| No Intervention: Control Condition<br>Subjects will perform standard clinical testing for balance and gait without SVS | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in balance performance | Change in balance performance during balance testing by measuring sway score across tested levels of GVR amplitude and control condition. | Through study completion, approximately 1.5 hours |