Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness

Not Applicable

Completed

• Conditions: Vestibular Time Constant; Seasickness; Motion Sickness; Habituation
• Interventions: Procedure: GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol; Procedure: Sham procedure

• Registration Number: NCT05004818
• Lead Sponsor: Medical Corps, Israel Defense Force

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-01
• Primary Completion: 2018-01-01
• Study Completion: 2019-07-01
• Status Verified: 2021-08
• Study First Submitted: 2021-08-11
• Study First Submitted QC: 2021-08-11
• Last Update Submitted: 2021-08-11
• Study First Posted: 2021-08-13
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GVS stimulation coupled with inverse phase rotatory chair stimulation	GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol	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.
sham 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.

Primary Outcome Measures

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