An interventional study of GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol and Sham procedure in Motion Sickness, Seasickness and Habituation, sponsored by Medical Corps, Israel Defense Force. Completed. Open to male participants aged 19 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-13.
Sponsored by Medical Corps, Israel Defense Force · Not applicable, Interventional, and Treatment
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.
50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.
This study's enrollment of 54 is close to the median of 59 across 44 interventional studies indexed under Motion Sickness.
Browse Motion Sickness studies →Medical Corps, Israel Defense Force is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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. No active stimulus was given.
Vestibular time constant
Vestibular time constant was measured using repeated rotatory chair stimulation in step protocol.
Time frame: Until one month following the intervention
Seasickness severity
Seasickness severity as determined by Wiker questionnaire at set time frames following the intervention
Time frame: Until one month following the intervention
scopolamine drug prescription
scopolamine drug prescriptions were calculated for each participant and compared between the two groups
Time frame: 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
Time frame: Until three months following the intervention
No study locations are listed for this record.
Plan to share: No
Ran from Aug 2016 to primary completion in Jan 2018, 17 months.
Of 15 interventional studies with no phase under Motion Sickness, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 29. This study's 17 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Medical Corps, Israel Defense Force