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Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness

Primary Purpose

Motion Sickness, Seasickness, Habituation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol
Sham procedure
Sponsored by
Medical Corps, Israel Defense Force
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motion Sickness focused on measuring Motion Sickness, Seasickness, Galvanic vestibular stimulation, Rotatory chair, Vestibular time constant

Eligibility Criteria

19 Years - 44 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • maximum score of 7 on the Wiker seasickness questionnaire in moderate sea conditions, with wave height of 0 - 1.5 m
  • All had been sailing regularly for at least six months before enrolling in the study

Exclusion Criteria:

  • history of hearing loss
  • otoscopic findings of ear pathology
  • an implanted electrode
  • a finding of vestibulopathy on otoneurologic examination
  • withdrawal by any subject of his informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    sham procedure

    GVS stimulation coupled with inverse phase rotatory chair stimulation

    Arm Description

    Participants with severe motion sickness were sited in the the rotatory chair with the videonystagmography recorder masking their eyes, while two galvanic vestibular stimulation electrodes were connected to the mastoid processes. No active stimulus was given.

    Participants with severe motion sickness were sited in the the rotatory chair with the videonystagmography recorder masking their eyes, while two galvanic vestibular stimulation electrodes were connected to the mastoid processes. The rotatory chair was activated in sinusoidal harmonic acceleration protocol in inverse phase to galvanic vestibular stimulation.

    Outcomes

    Primary Outcome Measures

    Vestibular time constant
    Vestibular time constant was measured using repeated rotatory chair stimulation in step protocol.
    Seasickness severity
    Seasickness severity as determined by Wiker questionnaire at set time frames following the intervention
    scopolamine drug prescription
    scopolamine drug prescriptions were calculated for each participant and compared between the two groups
    Anti-motion sickness clinic visits
    Anti-motion sickness clinic visits were calculated for each participant and compared between the two groups

    Secondary Outcome Measures

    Full Information

    First Posted
    August 11, 2021
    Last Updated
    August 11, 2021
    Sponsor
    Medical Corps, Israel Defense Force
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05004818
    Brief Title
    Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness
    Official Title
    Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    January 1, 2018 (Actual)
    Study Completion Date
    July 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical Corps, Israel Defense Force

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    subjects with severe seasickness, who failed to habituate to sea conditions after at least six month of active sailing, were enrolled to the single-blind randomized control study. The intervention group was treated with rotatory chair stimulation at sinusoidal harmonic acceleration protocol coupled with galvanic vestibular stimulation to the mastoid processes. This unique procedure was hypothesized to promote habituation to seasickness. The control group underwent a sham procedure. All study participants filled out seasickness questionnaires at set time points following the intervention and underwent repeated step testing to determine their vestibular time constant. The number of anti-motion sickness clinic visits and scopolamine prescriptions was also recorded in the three months period following the intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Motion Sickness, Seasickness, Habituation, Vestibular Time Constant
    Keywords
    Motion Sickness, Seasickness, Galvanic vestibular stimulation, Rotatory chair, Vestibular time constant

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    sham procedure
    Arm Type
    Sham Comparator
    Arm Description
    Participants with severe motion sickness were sited in the the rotatory chair with the videonystagmography recorder masking their eyes, while two galvanic vestibular stimulation electrodes were connected to the mastoid processes. No active stimulus was given.
    Arm Title
    GVS stimulation coupled with inverse phase rotatory chair stimulation
    Arm Type
    Experimental
    Arm Description
    Participants with severe motion sickness were sited in the the rotatory chair with the videonystagmography recorder masking their eyes, while two galvanic vestibular stimulation electrodes were connected to the mastoid processes. The rotatory chair was activated in sinusoidal harmonic acceleration protocol in inverse phase to galvanic vestibular stimulation.
    Intervention Type
    Procedure
    Intervention Name(s)
    GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol
    Intervention Description
    GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol
    Intervention Type
    Procedure
    Intervention Name(s)
    Sham procedure
    Intervention Description
    Participants with severe motion sickness were sited in the the rotatory chair with the videonystagmography recorder masking their eyes, while two galvanic vestibular stimulation electrodes were connected to the mastoid processes. No active stimulus was given.
    Primary Outcome Measure Information:
    Title
    Vestibular time constant
    Description
    Vestibular time constant was measured using repeated rotatory chair stimulation in step protocol.
    Time Frame
    Until one month following the intervention
    Title
    Seasickness severity
    Description
    Seasickness severity as determined by Wiker questionnaire at set time frames following the intervention
    Time Frame
    Until one month following the intervention
    Title
    scopolamine drug prescription
    Description
    scopolamine drug prescriptions were calculated for each participant and compared between the two groups
    Time Frame
    Until three months following the intervention
    Title
    Anti-motion sickness clinic visits
    Description
    Anti-motion sickness clinic visits were calculated for each participant and compared between the two groups
    Time Frame
    Until three months following the intervention

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    44 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: maximum score of 7 on the Wiker seasickness questionnaire in moderate sea conditions, with wave height of 0 - 1.5 m All had been sailing regularly for at least six months before enrolling in the study Exclusion Criteria: history of hearing loss otoscopic findings of ear pathology an implanted electrode a finding of vestibulopathy on otoneurologic examination withdrawal by any subject of his informed consent.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dror Tal, PhD
    Organizational Affiliation
    The Israel Naval Medical Institute, IDF Medical Corps, Haifa, Israel
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34782915
    Citation
    Gutkovich YE, Lagami D, Jamison A, Fonar Y, Tal D. Galvanic vestibular stimulation as a novel treatment for seasickness. Exp Brain Res. 2022 Feb;240(2):429-437. doi: 10.1007/s00221-021-06263-w. Epub 2021 Nov 15.
    Results Reference
    derived

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