What is the mechanism of action of this treatment?

Motion sickness treatments often target the vestibular system, which is responsible for balance and spatial orientation. Galvanic Vestibular Stimulation (GVS) works by delivering small electrical currents to the vestibular nerves, modulating their activity to reduce the sensory mismatch that causes motion sickness. This is important for patients because it directly addresses the root cause of motion sickness—disrupted vestibular signals—potentially providing more effective and immediate relief compared to traditional treatments like antihistamines or anticholinergics, which primarily manage symptoms rather than the underlying cause.

What side effects are associated with this type of intervention?

Common treatments for motion sickness include medications like antihistamines (e.g., dimenhydrinate, meclizine) and anticholinergics (e.g., scopolamine). These can cause side effects such as drowsiness, dry mouth, blurred vision, and dizziness. Galvanic Vestibular Stimulation (GVS), a newer approach being studied, aims to modulate the vestibular system to reduce motion sickness. While specific side effects of GVS are not well-documented, potential risks may include mild skin irritation at the electrode site, dizziness, and discomfort during stimulation. Further studies are needed to fully understand the safety profile of GVS.

What prior FDA approvals exist?

The FDA has approved several treatments for motion sickness, including hyoscine hydrobromide (scopolamine), which has been shown to reduce symptoms effectively. Other common treatments include antihistamines like dimenhydrinate and meclizine. Galvanic Vestibular Stimulation (GVS) is an investigational approach that aims to reduce motion sickness by modulating the vestibular system, but it is not yet FDA-approved.

What other types of research exist?

Promising novel alternatives to Galvanic Vestibular Stimulation for motion sickness include the use of wearable adaptive vestibular stimulators, which aim to improve current GVS technology. Additionally, advancements in virtual reality (VR) simulation technology that incorporate vestibular modulation may also offer new treatment options for motion sickness patients in 2024.

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Vestibular Stimulation for Motion Sickness

N/A

Recruiting

Led By Gaurav Pradhan, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be able to consent to participate themselves and be 21 to 55 years of age

Be between 18 and 65 years old

Must not have

Women who are pregnant

History of vestibular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after each flight stimulation session, approximately 1 hour

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new wearable device that uses small electrical currents to help people who get motion sickness from virtual reality. The device works by sending signals to the balance system in your inner ear, helping your brain match what you see in VR with what you feel. This could make VR more comfortable and realistic for users.

Who is the study for?

This trial is for English-speaking adults aged 21 to 55 who can attend sessions in Scottsdale, AZ. It's not for those with vestibular diseases, migraines, severe balance or motion sensitivity issues, or pregnant women.

What is being tested?

The study tests a new wearable device designed to reduce VR-induced motion sickness using Galvanic Vestibular Stimulation (GVS), alongside flight simulations and balance assessments on a force plate system.

What are the potential side effects?

Potential side effects may include discomfort from the GVS device, dizziness during or after stimulation, nausea related to VR simulation, and fatigue from participation in the study activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 21 and 55 years old and can consent to participate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently pregnant.

Select...

I have had a disorder affecting my balance.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after balance testing in each session, approximately 1 hour

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after balance testing in each session, approximately 1 hour

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after balance testing in each session, approximately 1 hour for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

COG Sway velocity

Pensacola Diagnostic Index-based motion sickness questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Positive GVS During VR Flight SimulationExperimental Treatment2 Interventions

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

Group II: Positive GVS During 3-DOF Bertec Portable Essential's dual-balance force plate systemExperimental Treatment2 Interventions

Subjects will receive positive galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system.

Group III: No GVS During VR Flight SimulationExperimental Treatment1 Intervention

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

Group IV: No GVS During 3-DOF Bertec Portable Essential's dual-balance force plate systemExperimental Treatment1 Intervention

Subjects will not receive any galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system.

Group V: Negative GVS During VR Flight SimulationExperimental Treatment2 Interventions

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

Group VI: Negative GVS During 3-DOF Bertec Portable Essential's dual-balance force plate systemExperimental Treatment2 Interventions

Subjects will receive negative galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Motion sickness treatments often target the vestibular system, which is responsible for balance and spatial orientation. Galvanic Vestibular Stimulation (GVS) works by delivering small electrical currents to the vestibular nerves, modulating their activity to reduce the sensory mismatch that causes motion sickness. This is important for patients because it directly addresses the root cause of motion sickness—disrupted vestibular signals—potentially providing more effective and immediate relief compared to traditional treatments like antihistamines or anticholinergics, which primarily manage symptoms rather than the underlying cause.

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