Motion SicknessNCT05004818
Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness
A study testing GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol in people with Motion Sickness and Seasickness, run by Medical Corps, Israel Defense Force.
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. Read more about this study
- Who is it for?
- Ages 19 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Motion Sickness, Seasickness, Habituation
- What is being tested?
- GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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
- Being tested
- GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol, Sham procedure
- Keywords
- Motion Sickness, Seasickness, Galvanic vestibular stimulation, Rotatory chair, Vestibular time constant
- Medical subject headings
- Motion Sickness, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocolProcedure or surgery
GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol
Sham procedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibular time constant
Vestibular time constant was measured using repeated rotatory chair stimulation in step protocol.
Measured: Until one month following the intervention
Seasickness severity
Seasickness severity as determined by Wiker questionnaire at set time frames following the intervention
Measured: Until one month following the intervention
scopolamine drug prescription
scopolamine drug prescriptions were calculated for each participant and compared between the two groups
Measured: 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
Measured: Until three months following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Aug 2016
- Primary completion1 Jan 2018
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motion SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dror Tal, PhD, Principal investigator, The Israel Naval Medical Institute, IDF Medical Corps, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004818
- Sponsor's protocol ID
- IDF 1298-2013
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34782915
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness
- ClinicalTrials.gov ID
- NCT05004818
- Acronym / sponsor ID
- IDF 1298-2013
- Conditions
- Motion Sickness, Seasickness, Habituation, Vestibular Time Constant
- Keywords
- Motion Sickness, Seasickness, Galvanic vestibular stimulation, Rotatory chair, Vestibular time constant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham procedure | Sham comparator | Procedure: Sham procedureParticipants 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. |
| GVS stimulation coupled with inverse phase rotatory chair stimulation | Experimental | Procedure: GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocolParticipants 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. |
Who may qualify
- Ages
- 19 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocolGVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol | Procedure or surgery | GVS stimulation coupled with inverse phase rotatory chair stimulation |
| Sham procedureParticipants 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 or surgery | sham procedure |
Primary outcome
Vestibular time constant
Time frame: Until one month following the intervention
Vestibular time constant was measured using repeated rotatory chair stimulation in step protocol.
Seasickness severity
Time frame: Until one month following the intervention
Seasickness severity as determined by Wiker questionnaire at set time frames following the intervention
scopolamine drug prescription
Time frame: Until three months following the intervention
scopolamine drug prescriptions were calculated for each participant and compared between the two groups
Anti-motion sickness clinic visits
Time frame: Until three months following the intervention
Anti-motion sickness clinic visits were calculated for each participant and compared between the two groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Derived from this study: PubMed 34782915Gutkovich 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dror Tal, PhD principal investigator
The Israel Naval Medical Institute, IDF Medical Corps, Haifa, Israel
Questions about this trial
What is this clinical trial studying?
A study testing GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol in people with Motion Sickness and Seasickness, run by Medical Corps, Israel Defense Force.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vestibular time constant (time frame: Until one month following the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05004818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.