Three-Axis Wearable Adaptive Vestibular Stimulator

N/AActive Not RecruitingNCT06106256

Mayo Clinic40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Motion Sickness

Interventions

Galvanic Vestibular Stimulation (GVS)DEVICE

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

Flight simulations in virtual reality (VR)OTHER

Highly immersive, 3D virtual flight simulation environment

3-DOF Bertec Portable Essential's dual-balance force plate systemOTHER

Firm surface/plate to stand on while being presented disorienting visual patters of moving vertical and/or horizontal bars of alternating black and white.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

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".

Time frame: 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.

Time frame: Immediately after balance testing in each session, approximately 1 hour

Data from ClinicalTrials.gov

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