Three-Axis Wearable Adaptive Vestibular Stimulator

Study Overview
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Brief Summary
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The purpose of this study is to improve current galvanic vestibular stimulation (GVS) technology to ease the motion sickness often associated with virtual reality (VR) simulation.

Detailed Description
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The Three-Axis Wearable Adaptive Vestibular Stimulator (3WAVeS) technology that combines galvanic vestibular stimulation (GVS) and Virtual Reality (VR) will not only increase VR-based simulation realism and presence, but will also mitigate the motion sickness often associated with VR simulation by re-coupling the vestibular and ocular inputs to the VR user. Additionally, due to GVS technology's ability to accurately provide continuous inputs to the vestibular system, 3WAVeS can intentionally simulate high-fidelity effects of spatial disorientation for training purposes.

Official Title
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3WAVeS: Three-Axis Wearable Adaptive Vestibular Stimulator

Conditions
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Motion Sickness

Intervention / Treatment
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* Device: Galvanic Vestibular Stimulation (GVS)
* Other: Flight simulations in virtual reality (VR)
* Other: 3-DOF Bertec Portable Essential's dual-balance force plate system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For our purposes, participants must be able to consent to participate themselves and 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, although all participants must be fluent speakers of English. Exclusion Criteria: - History of vestibular disease, migraine, or significant balance disorder; history of severe motion sensitivity, women who are pregnant.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive GVS During VR Flight Simulation<br>Subjects will receive positive galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR). | Device: Galvanic Vestibular Stimulation (GVS)<br>* Four electrodes, forehead, behind both ears, and back of your neck, provide bidirectional electrical stimulation and receive information about the amplitude delivered accounting for skin impedance<br>Other: Flight simulations in virtual reality (VR)<br>* Highly immersive, 3D virtual flight simulation environment<br>|
| Experimental: Negative GVS During VR Flight Simulation<br>Subjects will receive negative galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR). | Device: Galvanic Vestibular Stimulation (GVS)<br>* Four electrodes, forehead, behind both ears, and back of your neck, provide bidirectional electrical stimulation and receive information about the amplitude delivered accounting for skin impedance<br>Other: Flight simulations in virtual reality (VR)<br>* Highly immersive, 3D virtual flight simulation environment<br>|
| Experimental: No GVS During VR Flight Simulation<br>Subjects will not receive any galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR). | Other: Flight simulations in virtual reality (VR)<br>* Highly immersive, 3D virtual flight simulation environment<br>|
| Experimental: Positive GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system<br>Subjects will receive positive galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system. | Device: Galvanic Vestibular Stimulation (GVS)<br>* Four electrodes, forehead, behind both ears, and back of your neck, provide bidirectional electrical stimulation and receive information about the amplitude delivered accounting for skin impedance<br>Other: 3-DOF Bertec Portable Essential's dual-balance force plate system<br>* Firm surface/plate to stand on while being presented disorienting visual patters of moving vertical and/or horizontal bars of alternating black and white.<br>|
| Experimental: Negative GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system<br>Subjects will receive negative galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system. | Device: Galvanic Vestibular Stimulation (GVS)<br>* Four electrodes, forehead, behind both ears, and back of your neck, provide bidirectional electrical stimulation and receive information about the amplitude delivered accounting for skin impedance<br>Other: 3-DOF Bertec Portable Essential's dual-balance force plate system<br>* Firm surface/plate to stand on while being presented disorienting visual patters of moving vertical and/or horizontal bars of alternating black and white.<br>|
| Experimental: No GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system<br>Subjects will not receive any galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system. | Other: 3-DOF Bertec Portable Essential's dual-balance force plate system<br>* Firm surface/plate to stand on while being presented disorienting visual patters of moving vertical and/or horizontal bars of alternating black and white.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pensacola Diagnostic Index-based motion sickness questionnaire | This index allowed a comparison of motion sickness severity across subjects that may each present with a different constellation of symptoms like nausea, skin color, sweating, salivation, drowsiness, headache, and dizziness. The approach is to have the subject and/or observer grade the subjective intensity of different modalities of symptoms and signs (described below) as slight, moderate or severe. Overall motion sickness severity is then derived from a sum of scores resulting in a weighted malaise index. | Immediately after each flight stimulation session, approximately 1 hour | 
| COG Sway velocity | The sway angle of the center of gravity (COG) is the measure the amount of sway in any direction. The COG sway velocity is the ratio of the distance traveled by the COG (degrees) to the time (sec) of the trial. | Immediately after balance testing in each session, approximately 1 hour |