Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness

August 11, 2021 updated by: Medical Corps, Israel Defense Force
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 44 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: sham procedure
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.
Procedure: Sham procedure
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.
EXPERIMENTAL: GVS stimulation coupled with inverse phase rotatory chair stimulation
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.
Procedure: GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol
GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Corps, Israel Defense Force

Investigators

  • Principal Investigator: Dror Tal, PhD, The Israel Naval Medical Institute, IDF Medical Corps, Haifa, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2016

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

July 1, 2019

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (ACTUAL)

August 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDF 1298-2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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