Three-Axis Wearable Adaptive Vestibular Stimulator
3WAVeS: Three-Axis Wearable Adaptive Vestibular Stimulator
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2023
CompletedFirst Posted
Study publicly available on registry
October 30, 2023
CompletedStudy Start
First participant enrolled
November 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJanuary 30, 2026
January 1, 2026
2.1 years
October 24, 2023
January 28, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (6)
Positive GVS During VR Flight Simulation
EXPERIMENTALSubjects will receive positive galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR).
Negative GVS During VR Flight Simulation
EXPERIMENTALSubjects will receive negative galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR).
No GVS During VR Flight Simulation
EXPERIMENTALSubjects will not receive any galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR).
Positive GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system
EXPERIMENTALSubjects will receive positive galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system.
Negative GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system
EXPERIMENTALSubjects will receive negative galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system.
No GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system
EXPERIMENTALSubjects will not receive any galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system.
Interventions
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
Highly immersive, 3D virtual flight simulation environment
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- History of vestibular disease, migraine, or significant balance disorder; history of severe motion sensitivity, women who are pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gaurav Pradhan, PhD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will be blinded to the galvanic stimulation (GVS) intervention.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 24, 2023
First Posted
October 30, 2023
Study Start
November 15, 2023
Primary Completion
December 10, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share