Vestibular Stimulation for Motion Sickness

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Vestibular disease, Migraine, Balance disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Three-Axis Wearable Adaptive Vestibular Stimulator treatment for motion sickness?

Research shows that a similar treatment, galvanic vestibular stimulation (GVS), when combined with specific chair movements, can reduce motion sickness symptoms and the need for medication in people who are prone to seasickness. This suggests that using vestibular stimulation techniques can help manage motion sickness. ^{1 2 3 4 5}

Is vestibular stimulation safe for humans?

The research on transauricular electrical stimulation (tES), a type of vestibular stimulation, suggests it may be safe for humans as it was tested on healthy participants without reported adverse effects. This study indicates that tES could be a non-drug method to help manage motion sickness by balancing the autonomic nervous system. ^{1 2 3 6 7}

How does vestibular stimulation treatment for motion sickness differ from other treatments?

Vestibular stimulation treatment for motion sickness is unique because it uses electrical signals to stimulate the vestibular system (the part of the inner ear that helps control balance and eye movements), which can enhance vestibulo-motor responses and improve comfort compared to traditional methods. This approach is different from typical treatments like medications, as it directly targets the sensory system responsible for balance and motion perception. ^{1 8 9 10 11}

Research Team

Gaurav Pradhan, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

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

I can go to the Mayo Clinic in Scottsdale, AZ for sessions.

I am fluent in English.

Exclusion Criteria

I am currently pregnant.

I have had a disorder affecting my balance.

I have a history of migraines.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive galvanic vestibular stimulation (GVS) during various simulations to assess its effects on motion sickness and spatial disorientation.

6 weeks

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Three-Axis Wearable Adaptive Vestibular Stimulator

Trial Overview 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.

Participant Groups

Group I: Positive GVS During VR Flight Simulation Experimental Treatment 2 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 system Experimental Treatment 2 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 Simulation Experimental Treatment 1 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 system Experimental Treatment 1 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 Simulation Experimental Treatment 2 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 system Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

The study involved 70 participants (35 with motion sickness and 35 without) aged 18-40, and it found that both groups showed significant differences in their ability to correctly respond to optokinetic and rotational stimuli during the fHIT test.

The results suggest that fHIT can be an effective objective test for diagnosing motion sickness, as individuals with motion sickness were notably affected by these stimuli compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of effects of optokinetic and rotational stimuli with functional head impulse test (fHIT) in individuals with motion sickness. Karababa, E., Satar, B., Genç, H.[2023]

The new multichannel vestibular prosthesis (MVP) is designed to restore vestibular function in individuals with bilateral loss of vestibular sensation, potentially alleviating symptoms like chronic disequilibrium and postural instability.

Improvements in the MVP include a smaller size, lower power consumption, and enhanced electrode design for better nerve coupling, which were validated through both bench-top tests and in vivo experiments with a rhesus macaque monkey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and performance of a multichannel vestibular prosthesis that restores semicircular canal sensation in rhesus monkey. Chiang, B., Fridman, GY., Dai, C., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of effects of optokinetic and rotational stimuli with functional head impulse test (fHIT) in individuals with motion sickness. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Decreasing motion sickness by mixing different techniques. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Failure of cetirizine and fexofenadine to prevent motion sickness. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

The retention of adaptation to motion sickness eliciting stimulation. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Galvanic vestibular stimulation as a novel treatment for seasickness. [2022]

6. England pubmed.ncbi.nlm.nih.gov

On the potential of transauricular electrical stimulation to reduce visually induced motion sickness. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Toward Predicting Motion Sickness Using Virtual Reality and a Moving Platform Assessing Brain, Muscles, and Heart Signals. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Multichannel vestibular prosthesis employing modulation of pulse rate and current with alignment precompensation elicits improved VOR performance in monkeys. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Electrical vestibular stimuli to enhance vestibulo-motor output and improve subject comfort. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Vestibulo-ocular reflex responses to a multichannel vestibular prosthesis incorporating a 3D coordinate transformation for correction of misalignment. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Design and performance of a multichannel vestibular prosthesis that restores semicircular canal sensation in rhesus monkey. [2021]