Non-pharmaceutical Motion Sickness Mitigation

Study Overview
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Brief Summary
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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.

Official Title
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Non-pharmaceutical Motion Sickness Mitigation

Conditions
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Healthy

Intervention / Treatment
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* Device: Galvanic Vestibular Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Galvanic Vestibular Stimulation During the Entire Session<br>Subjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from beginning. | Device: Galvanic Vestibular Stimulation<br>* 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.<br>|
| No Intervention: No Galvanic Vestibular Stimulation<br>Subjects were not given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation entire session. | |
| Experimental: Galvanic Vestibular Stimulation Starting From Mid-session<br>Subjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from the middle of the session. | Device: Galvanic Vestibular Stimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | During the rotation of the chair, approximately 1 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motion Sickness Questionnaire | subjective experiences of motion sickness in a scale of 0-10 (0=not at all; 10=most severe) | During the rotation of the chair, approximately 1 hr |