Healthy
Conditions
Brief 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.
Interventions
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motion Perception | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motion Sickness Questionnaire | During the rotation of the chair, approximately 1 hr | subjective experiences of motion sickness in a scale of 0-10 (0=not at all; 10=most severe) |
Countries
United States
Participant flow
Pre-assignment details
Total of 29 participants were enrolled to receive all interventions, however the order the intervention was received was randomized. All subjects completed the first experimental visit. 2 subjects withdrew from the study prior to the start of the second experimental visit.
Participants by arm
| Arm | Count |
|---|---|
| Galvanic Vestibular Stimulation 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).
Galvanic Vestibular Stimulation: 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. | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Galvanic Vestibular Stimulation | — |
|---|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 9.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 29 participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 0 / 29 | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 | 0 / 29 |
Outcome results
Primary
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)
Time frame: During the rotation of the chair, approximately 1 hr
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Galvanic Vestibular Stimulation | Motion Perception | No GVS | 55.3 score on a scale | Standard Deviation 32.2 |
| Galvanic Vestibular Stimulation | Motion Perception | GVS Entire Session | 49.7 score on a scale | Standard Deviation 34 |
| Galvanic Vestibular Stimulation | Motion Perception | GVS from Mid-Session | 50.1 score on a scale | Standard Deviation 33.6 |
Secondary
Motion Sickness Questionnaire
subjective experiences of motion sickness in a scale of 0-10 (0=not at all; 10=most severe)
Time frame: During the rotation of the chair, approximately 1 hr
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Galvanic Vestibular Stimulation | Motion Sickness Questionnaire | No GVS | 3.0 score on a scale | Standard Deviation 2.9 |
| Galvanic Vestibular Stimulation | Motion Sickness Questionnaire | GVS Entire Session | 3.2 score on a scale | Standard Deviation 3.2 |
| Galvanic Vestibular Stimulation | Motion Sickness Questionnaire | GVS from Mid-Session | 3.4 score on a scale | Standard Deviation 3.1 |