Motion SicknessNCT06106256
Three-Axis Wearable Adaptive Vestibular Stimulator
A study testing Galvanic Vestibular Stimulation (GVS), Flight simulations in virtual reality (VR) and 3-DOF Bertec Portable Essential's dual-balance force plate system in people with Motion Sickness, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Motion Sickness
- What is being tested?
- Galvanic Vestibular Stimulation (GVS), Flight simulations in virtual reality (VR) and 3-DOF Bertec Portable Essential's dual-balance force plate system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- History of vestibular disease, migraine, or significant balance disorder; history of severe motion sensitivity, women who are pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Motion Sickness
- Being tested
- Galvanic Vestibular Stimulation (GVS), Flight simulations in virtual reality (VR), 3-DOF Bertec Portable Essential's dual-balance force plate system
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galvanic Vestibular Stimulation (GVS)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)Other
Highly immersive, 3D virtual flight simulation environment
3-DOF Bertec Portable Essential's dual-balance force plate systemOther
Firm surface/plate to stand on while being presented disorienting visual patters of moving vertical and/or horizontal bars of alternating black and white.
| Study group | Role | What they receive |
|---|---|---|
| Positive GVS During VR Flight Simulation | Experimental | Subjects will receive positive galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR). Receives: Device: Galvanic Vestibular Stimulation (GVS); Other: Flight simulations in virtual reality (VR) |
| Negative GVS During VR Flight Simulation | Experimental | Subjects will receive negative galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR). Receives: Device: Galvanic Vestibular Stimulation (GVS); Other: Flight simulations in virtual reality (VR) |
| No GVS During VR Flight Simulation | Experimental | Subjects will not receive any galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR). Receives: Other: Flight simulations in virtual reality (VR) |
| Positive GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system | Experimental | Subjects will receive positive galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system. Receives: Device: Galvanic Vestibular Stimulation (GVS); Other: 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 | Experimental | Subjects will receive negative galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system. Receives: Device: Galvanic Vestibular Stimulation (GVS); Other: 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 | Experimental | Subjects will not receive any galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system. Receives: Other: 3-DOF Bertec Portable Essential's dual-balance force plate system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: Immediately after balance testing in each session, approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start15 Nov 2023
- Primary completion10 Dec 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motion SicknessStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaurav N. Pradhan, Mayo Clinic
- Investigators
- Gaurav Pradhan, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106256
- Sponsor's protocol ID
- 23-002124
- Status last verified
- Jan 2026
- First submitted
- 24 Oct 2023
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3WAVeS: Three-Axis Wearable Adaptive Vestibular Stimulator
- ClinicalTrials.gov ID
- NCT06106256
- Acronym / sponsor ID
- 23-002124
- Conditions
- Motion Sickness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Positive GVS During VR Flight Simulation | Experimental | Device: Galvanic Vestibular Stimulation (GVS), Other: Flight simulations in virtual reality (VR)Subjects will receive positive galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR). |
| Negative GVS During VR Flight Simulation | Experimental | Device: Galvanic Vestibular Stimulation (GVS), Other: Flight simulations in virtual reality (VR)Subjects will receive negative galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR). |
| No GVS During VR Flight Simulation | Experimental | Other: Flight simulations in virtual reality (VR)Subjects 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 | Experimental | Device: Galvanic Vestibular Stimulation (GVS), Other: 3-DOF Bertec Portable Essential's dual-balance force plate systemSubjects 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 | Experimental | Device: Galvanic Vestibular Stimulation (GVS), Other: 3-DOF Bertec Portable Essential's dual-balance force plate systemSubjects 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 | Experimental | Other: 3-DOF Bertec Portable Essential's dual-balance force plate systemSubjects will not receive any galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- History of vestibular disease, migraine, or significant balance disorder; history of severe motion sensitivity, women who are pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Negative GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system, Negative GVS During VR Flight Simulation, Positive GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system, Positive GVS During VR Flight Simulation |
| Flight simulations in virtual reality (VR)Highly immersive, 3D virtual flight simulation environment | Other | Negative GVS During VR Flight Simulation, No GVS During VR Flight Simulation, Positive GVS During VR Flight Simulation |
| 3-DOF Bertec Portable Essential's dual-balance force plate systemFirm surface/plate to stand on while being presented disorienting visual patters of moving vertical and/or horizontal bars of alternating black and white. | Other | Negative GVS During 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, Positive GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system |
Primary outcome
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".
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaurav Pradhan, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galvanic Vestibular Stimulation (GVS), Flight simulations in virtual reality (VR) and 3-DOF Bertec Portable Essential's dual-balance force plate system in people with Motion Sickness, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pensacola Diagnostic Index-based motion sickness questionnaire (time frame: Immediately after each flight stimulation session, approximately 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.