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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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