Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness

Motion Sickness Clinical Trial

Official title:

Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05004818
• Other study ID #: IDF 1298-2013
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: July 1, 2019

Study information

• Verified date: August 2021
• Source: Medical Corps, Israel Defense Force
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 1, 2019
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Habituation
• Motion Sickness
• Seasickness

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical Corps, Israel Defense Force

Outcome

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