Three-Axis Wearable Adaptive Vestibular Stimulator

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT06106256
Collaborator
(none)
40
1
6
7
5.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Galvanic Vestibular Stimulation (GVS)
  • Other: Flight simulations in virtual reality (VR)
  • Other: 3-DOF Bertec Portable Essential's dual-balance force plate system
N/A

Detailed Description

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Masking Description:
Participants will be blinded to the galvanic stimulation (GVS) intervention.
Primary Purpose:
Treatment
Official Title:
3WAVeS: Three-Axis Wearable Adaptive Vestibular Stimulator
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Positive GVS During VR Flight Simulation

Subjects will receive positive galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR).

Device: Galvanic Vestibular Stimulation (GVS)
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

Other: Flight simulations in virtual reality (VR)
Highly immersive, 3D virtual flight simulation environment

Experimental: Negative GVS During VR Flight Simulation

Subjects will receive negative galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR).

Device: Galvanic Vestibular Stimulation (GVS)
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

Other: Flight simulations in virtual reality (VR)
Highly immersive, 3D virtual flight simulation environment

Experimental: No GVS During VR Flight Simulation

Subjects will not receive any galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR).

Other: Flight simulations in virtual reality (VR)
Highly immersive, 3D virtual flight simulation environment

Experimental: Positive GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system

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)
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

Other: 3-DOF Bertec Portable Essential's dual-balance force plate system
Firm surface/plate to stand on while being presented disorienting visual patters of moving vertical and/or horizontal bars of alternating black and white.

Experimental: Negative GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system

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)
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

Other: 3-DOF Bertec Portable Essential's dual-balance force plate system
Firm surface/plate to stand on while being presented disorienting visual patters of moving vertical and/or horizontal bars of alternating black and white.

Experimental: No GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system

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

Outcome Measures

Primary Outcome Measures

  1. Pensacola Diagnostic Index-based motion sickness questionnaire [Immediately after each flight stimulation session, approximately 1 hour]

    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".

  2. COG Sway velocity [Immediately after balance testing in each session, approximately 1 hour]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Arizona Scottsdale Arizona United States 85259

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Gaurav Pradhan, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Gaurav N. Pradhan, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT06106256
Other Study ID Numbers:
  • 23-002124
First Posted:
Oct 30, 2023
Last Update Posted:
Oct 30, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 30, 2023