Three-Axis Wearable Adaptive Vestibular Stimulator

NCT ID: NCT06106256

Last Updated: 2026-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Motion Sickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will be blinded to the galvanic stimulation (GVS) intervention.

Study Groups

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Positive GVS During VR Flight Simulation

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

Group Type EXPERIMENTAL

Galvanic Vestibular Stimulation (GVS)

Intervention Type 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)

Intervention Type OTHER

Highly immersive, 3D virtual flight simulation environment

Negative GVS During VR Flight Simulation

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

Group Type EXPERIMENTAL

Galvanic Vestibular Stimulation (GVS)

Intervention Type 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)

Intervention Type OTHER

Highly immersive, 3D virtual flight simulation environment

No GVS During VR Flight Simulation

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

Group Type EXPERIMENTAL

Flight simulations in virtual reality (VR)

Intervention Type OTHER

Highly immersive, 3D virtual flight simulation environment

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.

Group Type EXPERIMENTAL

Galvanic Vestibular Stimulation (GVS)

Intervention Type 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

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

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Galvanic Vestibular Stimulation (GVS)

Intervention Type 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

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

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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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

Intervention Type DEVICE

Flight simulations in virtual reality (VR)

Highly immersive, 3D virtual flight simulation environment

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Gaurav N. Pradhan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaurav Pradhan, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Arizona

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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23-002124

Identifier Type: -

Identifier Source: org_study_id

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