Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness

NCT05004818 | Completed DMC

• 1 other identifier: IDF 1298-2013
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Motion Sickness; Seasickness; Habituation; Vestibular Time Constant

Keywords

Motion Sickness; Seasickness; Galvanic vestibular stimulation; Rotatory chair; Vestibular time constant

Outcome Measures

Primary Outcomes (4)

• Vestibular time constant

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

  Until one month following the intervention

• Seasickness severity

  Seasickness severity as determined by Wiker questionnaire at set time frames following the intervention

  Until one month following the intervention

• scopolamine drug prescription

  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

  Anti-motion sickness clinic visits were calculated for each participant and compared between the two groups

  Until three months following the intervention

Study Arms (2)

sham procedure

SHAM COMPARATOR

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

GVS stimulation coupled with inverse phase rotatory chair stimulation

EXPERIMENTAL

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

Interventions

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

GVS stimulation coupled with inverse phase rotatory chair stimulation

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.

sham procedure

Eligibility Criteria

• Age: 19 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Corps, Israel Defense Force: lead

Related Publications (1)

• Gutkovich YE, Lagami D, Jamison A, Fonar Y, Tal D. Galvanic vestibular stimulation as a novel treatment for seasickness. Exp Brain Res. 2022 Feb;240(2):429-437. doi: 10.1007/s00221-021-06263-w. Epub 2021 Nov 15.

  PMID: 34782915 DERIVED

MeSH Terms

Conditions

Motion Sickness; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Dror Tal, PhD

  The Israel Naval Medical Institute, IDF Medical Corps, Haifa, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 13, 2021
• Study Start: August 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: July 1, 2019
• Last Updated: August 13, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share