HealthyNCT04859868

Non-pharmaceutical Motion Sickness Mitigation

A study testing Galvanic Vestibular Stimulation in people with Healthy, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is evaluate the effect of timing and magnitude on the administration of our nonpharmaceutical treatment to motion sickness, and to evaluate the effect of Galvanic Vestibular Stimulation (GVR) amplitude on functional fitness task performance. Read more about this study

Who is it for?: Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Galvanic Vestibular Stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited States
Study dates: 12 Mar 2021to 30 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Must be able to consent to participate themselves.
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.
Must be fluent speakers of English.

Who cannot join

History of vestibular disease, migraine, or significant balance disorder.
Traumatic brain injury.
Recent middle ear infection or recent motion sickness (within 72 hours).
History of severe motion sensitivity.
Women who are pregnant.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259

Other trials in United States

About this study

Conditions: Healthy
Being tested: Galvanic Vestibular Stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Galvanic Vestibular StimulationDevice
Low electrical currents to the vestibular system, to induce the realistic sensation of motion (i.e., the g-forces that occur during flight) as well as null out motion perception.

Study groups in NCT04859868
Study group	Role	What they receive
Galvanic Vestibular Stimulation During the Entire Session	Experimental	Subjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from beginning. Receives: Device: Galvanic Vestibular Stimulation
No Galvanic Vestibular Stimulation	No intervention	Subjects were not given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation entire session.
Galvanic Vestibular Stimulation Starting From Mid-session	Experimental	Subjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from the middle of the session. Receives: Device: Galvanic Vestibular Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Motion Perception
Motion Perception verbal report using a visual analog scale (1-100) will be recorded during the rotation of the chair (1=feeling no motion perception; 100=feeling the maximum motion perception)
Measured: During the rotation of the chair, approximately 1 hr

Secondary outcomes (1)

Motion Sickness Questionnaire
subjective experiences of motion sickness in a scale of 0-10 (0=not at all; 10=most severe)
Measured: During the rotation of the chair, approximately 1 hr

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 202130 Aug 2022

First posted26 Apr 2021
Study start12 Mar 2021
Primary completion30 Aug 2022
Study completion30 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies 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: Prevention
Allocation: Randomised
Intervention model: Crossover
Model description: Subjects attend four visits of the experiment on four separate days. Each visit will be an hour and a half long. In the first visit, subjects will perform batteries of tests that involve balance, cognition, and determine motion perception at different current levels using a rotating chair. In the next three visits, researchers will test the Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair be either turning stimulation ON from beginning, or middle or by not turning ON (the order will be randomized).
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04859868
Sponsor's protocol ID: 20-005763
Other IDs: 80NSSC21K0175
Status last verified: Sep 2023
First submitted: 1 Apr 2021
Last updated: 28 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-pharmaceutical Motion Sickness Mitigation
ClinicalTrials.gov ID: NCT04859868
Acronym / sponsor ID: 20-005763
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 12 Mar 2021 (actual)
Primary completion: 30 Aug 2022 (actual)
Study completion: 30 Aug 2022 (actual)
First posted: 26 Apr 2021 (actual)
Results: Posted 28 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3
Model description: Subjects attend four visits of the experiment on four separate days. Each visit will be an hour and a half long. In the first visit, subjects will perform batteries of tests that involve balance, cognition, and determine motion perception at different current levels using a rotating chair. In the next three visits, researchers will test the Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair be either turning stimulation ON from beginning, or middle or by not turning ON (the order will be randomized).

Arm	Type	Receives
Galvanic Vestibular Stimulation During the Entire Session	Experimental	Device: Galvanic Vestibular StimulationSubjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from beginning.
No Galvanic Vestibular Stimulation	No intervention	–Subjects were not given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation entire session.
Galvanic Vestibular Stimulation Starting From Mid-session	Experimental	Device: Galvanic Vestibular StimulationSubjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from the middle of the session.

Who may qualify

Ages: 21 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Must be able to consent to participate themselves.
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.
Must be fluent speakers of English.

Key exclusion criteria (5 listed)

History of vestibular disease, migraine, or significant balance disorder.
Traumatic brain injury.
Recent middle ear infection or recent motion sickness (within 72 hours).
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 StimulationLow electrical currents to the vestibular system, to induce the realistic sensation of motion (i.e., the g-forces that occur during flight) as well as null out motion perception.	Device	Galvanic Vestibular Stimulation During the Entire Session, Galvanic Vestibular Stimulation Starting From Mid-session

Primary outcome

Motion Perception
Time frame: During the rotation of the chair, approximately 1 hr
Motion Perception verbal report using a visual analog scale (1-100) will be recorded during the rotation of the chair (1=feeling no motion perception; 100=feeling the maximum motion perception)

1 secondary outcome

Motion Sickness Questionnaire
Time frame: During the rotation of the chair, approximately 1 hr

Results and safety

Results posted to the registry on 28 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GVS Entire Session, GVS From Mid-Session, Then No GVS	5	5
GVS Entire Session, No GVS, Then GVS From Mid-Session	5	5
GVS From Mid-Session, GVS Entire Session, Then No GVS	5	5
GVS From Mid-Session, No GVS, Then GVS Entire Session	4	4
No GVS, GVS From Mid-Session, Then GVS Entire Session	5	5
No GVS, GVS Entire Session, Then GVS From Mid-Session	5	5

Primary outcome: Motion Perception

Time frame: During the rotation of the chair, approximately 1 hr. Mean (Standard Deviation). Unit: score on a scale

Measure	Galvanic Vestibular Stimulation n = 27
No GVS	55.3 (32.2)
GVS Entire Session	49.7 (34.0)
GVS from Mid-Session	50.1 (33.6)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from baseline to end of study participation for a total of approximately 4 days on all participants.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Galvanic Vestibular Stimulation During the Entire Session	0 of 29 (0%)	0 of 29 (0%)	0 of 29
No Galvanic Vestibular Stimulation	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Galvanic Vestibular Stimulation Starting From Mid-session	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
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 N 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 in people with Healthy, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 28 Sep 2023. 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?

Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Motion Perception (time frame: During the rotation of the chair, approximately 1 hr). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04859868.

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 28 Sep 2023.