- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06106256
Three-Axis Wearable Adaptive Vestibular Stimulator
January 28, 2026 updated by: Gaurav N. Pradhan, Mayo Clinic
3WAVeS: Three-Axis Wearable Adaptive Vestibular Stimulator
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.
Study Overview
Status
Active, not recruiting
Conditions
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 Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic Arizona
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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).
|
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
|
|
Experimental: Negative GVS During VR Flight Simulation
Subjects will receive negative galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR).
|
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
|
|
Experimental: No GVS During VR Flight Simulation
Subjects will not receive any galvanic vestibular stimulation (GVS) during a flight simulation 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.
|
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
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.
|
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
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.
|
Firm surface/plate to stand on while being presented disorienting visual patters of moving vertical and/or horizontal bars of alternating black and white.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pensacola Diagnostic Index-based motion sickness questionnaire
Time Frame: 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".
|
Immediately after each flight stimulation session, approximately 1 hour
|
|
COG Sway velocity
Time Frame: 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.
|
Immediately after balance testing in each session, approximately 1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gaurav Pradhan, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2023
Primary Completion (Actual)
December 10, 2025
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
October 24, 2023
First Submitted That Met QC Criteria
October 24, 2023
First Posted (Actual)
October 30, 2023
Study Record Updates
Last Update Posted (Actual)
January 30, 2026
Last Update Submitted That Met QC Criteria
January 28, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-002124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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