Non-pharmaceutical Motion Sickness Mitigation

NCT04859868 | Completed Results FDA Device

• 2 other identifiers: 20-00576380NSSC21K0175
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Motion Sickness Questionnaire

  During the rotation of the chair, approximately 1 hr

Study Arms (3)

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.

Device: Galvanic Vestibular Stimulation

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.

Device: Galvanic Vestibular Stimulation

Interventions

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.

Galvanic Vestibular Stimulation During the Entire Session; Galvanic Vestibular Stimulation Starting From Mid-session

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Gaurav N. Pradhan, Ph.D.
• Organization: Mayo Clinic

Pradhan.Gaurav@mayo.edu

480-301-5351

Study Officials

• Gaurav N Pradhan, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 26, 2021
• Study Start: March 12, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)