Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness

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.

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Key information

Conditions

Motion Sickness Chemically-Induced Disorders Habituation Mental Disorders Pathological Conditions, Signs and Symptoms Seasickness Signs and Symptoms Substance-Related Disorders Vestibular Time Constant

Age range

19 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol

Procedure

GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol

Sham Procedure

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.

Primary outcomes

Vestibular time constant

Time frame: Until one month following the intervention

Vestibular time constant was measured using repeated rotatory chair stimulation in step protocol.
Seasickness severity

Time frame: Until one month following the intervention

Seasickness severity as determined by Wiker questionnaire at set time frames 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
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

Sponsors and collaborators

Lead sponsor

Medical Corps, Israel Defense Force

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2019
First posted: Aug 13, 2021
Registry last updated: Aug 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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