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| ID | Type | Description | Link |
|---|---|---|---|
| 80NSSC21K0175 | Other Grant/Funding Number | National Aeronautics and Space Administration |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galvanic Vestibular Stimulation | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaurav N Pradhan, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | GVS Entire Session, GVS From Mid-Session, Then No GVS | Subjects received Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from beginning for experimental visit 1; subjects received GVS ON from mid-session in the rotating chair for experimental visit 2; subjects received GVS stimulation OFF for entire session in rotating chair for experimental visit 3. 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. |
| FG001 | GVS Entire Session, No GVS, Then GVS From Mid-Session | Subjects received Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from beginning for experimental visit 1; subjects received GVS stimulation OFF for entire session in rotating chair for experimental visit 2; subjects received GVS ON from mid-session in the rotating chair for experimental visit 3. 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. |
| FG002 | GVS From Mid-Session, GVS Entire Session, Then No GVS | Subjects received Galvanic Vestibular Stimulation (GVS) ON from mid-session in the rotating chair for experimental visit 1; subjects received GVS to mitigate motion sickness in the rotating chair turning stimulation ON from beginning for experimental visit 2; subjects received GVS stimulation OFF for entire session in rotating chair for experimental visit 3. 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. |
| FG003 | GVS From Mid-Session, No GVS, Then GVS Entire Session | Subjects received Galvanic Vestibular Stimulation (GVS) ON from mid-session in the rotating chair for experimental visit 1; subjects received GVS stimulation OFF for entire session in rotating chair for experimental visit 2; subjects received GVS to mitigate motion sickness in the rotating chair turning stimulation ON from beginning for experimental visit 3. 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. |
| FG004 | No GVS, GVS From Mid-Session, Then GVS Entire Session | Subjects received Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation OFF from beginning for experimental visit 1; subjects received GVS ON from mid-session in the rotating chair for experimental visit 2; subjects received GVS stimulation ON for entire session in rotating chair for experimental visit 3. 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. |
| FG005 | No GVS, GVS Entire Session, Then GVS From Mid-Session | Subjects received Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation OFF from beginning for experimental visit 1; subjects received GVS stimulation ON for entire session in rotating chair for experimental visit 2; subjects received GVS ON from mid-session in the rotating chair for experimental visit 3. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Experimental Visit (1.5 Hour) |
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| Second Experimental Visit (1.5 Hour) |
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| Third Experimental Visit (1.5 Hour) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | score on a scale | During the rotation of the chair, approximately 1 hr |
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Adverse events were collected from baseline to end of study participation for a total of approximately 4 days on all participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Galvanic Vestibular Stimulation During the Entire Session | Subjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from beginning. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gaurav N. Pradhan, Ph.D. | Mayo Clinic | 480-301-5351 | Pradhan.Gaurav@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2020 | May 30, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 24, 2022 | Sep 7, 2023 | ICF_001.pdf |
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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).
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Motion Sickness Questionnaire | subjective experiences of motion sickness in a scale of 0-10 (0=not at all; 10=most severe) | Posted | Mean | Standard Deviation | score on a scale | During the rotation of the chair, approximately 1 hr |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | No Galvanic Vestibular Stimulation | Subjects were not given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation entire session. | 0 | 29 | 0 | 29 | 0 | 29 |
| EG002 | Galvanic Vestibular Stimulation Starting From Mid-session | Subjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from the middle of the session. 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. | 0 | 29 | 0 | 29 | 0 | 29 |
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| Title | Measurements |
|---|---|
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