Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness

Medical Corps, Israel Defense Force

Status: Completed

Conditions: Vestibular Time Constant; Seasickness; Habituation; Motion Sickness

Treatments: Procedure: GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol; Procedure: Sham procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT05004818

IDF 1298-2013

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: Male

Ages: 19 to 44 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

sham procedure

Sham Comparator group

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.

Treatment:

Procedure: Sham procedure

GVS stimulation coupled with inverse phase rotatory chair stimulation

Experimental group

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.

Treatment:

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