Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT05004818
Status:
COMPLETED
Last Update Posted:
2021-08-13
First Post:
2021-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009041', 'term': 'Motion Sickness'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-11', 'studyFirstSubmitDate': '2021-08-11', 'studyFirstSubmitQcDate': '2021-08-11', 'lastUpdatePostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vestibular time constant', 'timeFrame': 'Until one month following the intervention', 'description': 'Vestibular time constant was measured using repeated rotatory chair stimulation in step protocol.'}, {'measure': 'Seasickness severity', 'timeFrame': 'Until one month following the intervention', 'description': 'Seasickness severity as determined by Wiker questionnaire at set time frames following the intervention'}, {'measure': 'scopolamine drug prescription', 'timeFrame': 'Until three months following the intervention', 'description': 'scopolamine drug prescriptions were calculated for each participant and compared between the two groups'}, {'measure': 'Anti-motion sickness clinic visits', 'timeFrame': 'Until three months following the intervention', 'description': 'Anti-motion sickness clinic visits were calculated for each participant and compared between the two groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Motion Sickness', 'Seasickness', 'Galvanic vestibular stimulation', 'Rotatory chair', 'Vestibular time constant'], 'conditions': ['Motion Sickness', 'Seasickness', 'Habituation', 'Vestibular Time Constant']}, 'referencesModule': {'references': [{'pmid': '34782915', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* maximum score of 7 on the Wiker seasickness questionnaire in moderate sea conditions, with wave height of 0 - 1.5 m\n* All had been sailing regularly for at least six months before enrolling in the study\n\nExclusion Criteria:\n\n* history of hearing loss\n* otoscopic findings of ear pathology\n* an implanted electrode\n* a finding of vestibulopathy on otoneurologic examination\n* withdrawal by any subject of his informed consent.'}, 'identificationModule': {'nctId': 'NCT05004818', 'briefTitle': 'Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness', 'organization': {'class': 'OTHER', 'fullName': 'Medical Corps, Israel Defense Force'}, 'officialTitle': 'Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness', 'orgStudyIdInfo': {'id': 'IDF 1298-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'sham procedure', '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.', 'interventionNames': ['Procedure: Sham procedure']}, {'type': 'EXPERIMENTAL', 'label': 'GVS stimulation coupled with inverse phase rotatory chair stimulation', '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.', 'interventionNames': ['Procedure: GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol']}], 'interventions': [{'name': 'GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol', 'type': 'PROCEDURE', 'description': 'GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol', 'armGroupLabels': ['GVS stimulation coupled with inverse phase rotatory chair stimulation']}, {'name': 'Sham procedure', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['sham procedure']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dror Tal, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Israel Naval Medical Institute, IDF Medical Corps, Haifa, Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Corps, Israel Defense Force', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}