Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT04859868
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2021-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-pharmaceutical Motion Sickness Mitigation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Pradhan.Gaurav@mayo.edu', 'phone': '480-301-5351', 'title': 'Gaurav N. Pradhan, Ph.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from baseline to end of study participation for a total of approximately 4 days on all participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Galvanic Vestibular Stimulation During the Entire Session', 'description': 'Subjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from beginning.\n\nGalvanic Vestibular Stimulation: Low electrical currents to the vestibular system, to induce the realistic sensation of motion (i.e., the g-forces that occur during flight) as well as null out motion perception.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Galvanic Vestibular Stimulation', 'description': 'Subjects were not given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation entire session.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Galvanic Vestibular Stimulation Starting From Mid-session', 'description': 'Subjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from the middle of the session.\n\nGalvanic Vestibular Stimulation: Low electrical currents to the vestibular system, to induce the realistic sensation of motion (i.e., the g-forces that occur during flight) as well as null out motion perception.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Motion Perception', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Galvanic Vestibular Stimulation', 'description': 'Subjects attend four visits of the experiment on four separate days. Each visit will be an hour and a half long. In the first visit, subjects will perform batteries of tests that involve balance, cognition, and determine motion perception at different current levels using a rotating chair. In the next three visits, researchers will test the Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair be either turning stimulation ON from beginning, or middle or by not turning ON (the order will be randomized).\n\nGalvanic Vestibular Stimulation: Low electrical currents to the vestibular system, to induce the realistic sensation of motion (i.e., the g-forces that occur during flight) as well as null out motion perception.'}], 'classes': [{'title': 'No GVS', 'categories': [{'measurements': [{'value': '55.3', 'spread': '32.2', 'groupId': 'OG000'}]}]}, {'title': 'GVS Entire Session', 'categories': [{'measurements': [{'value': '49.7', 'spread': '34.0', 'groupId': 'OG000'}]}]}, {'title': 'GVS from Mid-Session', 'categories': [{'measurements': [{'value': '50.1', 'spread': '33.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the rotation of the chair, approximately 1 hr', 'description': 'Motion Perception verbal report using a visual analog scale (1-100) will be recorded during the rotation of the chair (1=feeling no motion perception; 100=feeling the maximum motion perception)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Motion Sickness Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Galvanic Vestibular Stimulation', 'description': 'Subjects attend four visits of the experiment on four separate days. Each visit will be an hour and a half long. In the first visit, subjects will perform batteries of tests that involve balance, cognition, and determine motion perception at different current levels using a rotating chair. In the next three visits, researchers will test the Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair be either turning stimulation ON from beginning, or middle or by not turning ON (the order will be randomized).\n\nGalvanic Vestibular Stimulation: Low electrical currents to the vestibular system, to induce the realistic sensation of motion (i.e., the g-forces that occur during flight) as well as null out motion perception.'}], 'classes': [{'title': 'No GVS', 'categories': [{'measurements': [{'value': '3.0', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'GVS Entire Session', 'categories': [{'measurements': [{'value': '3.2', 'spread': '3.2', 'groupId': 'OG000'}]}]}, {'title': 'GVS from Mid-Session', 'categories': [{'measurements': [{'value': '3.4', 'spread': '3.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the rotation of the chair, approximately 1 hr', 'description': 'subjective experiences of motion sickness in a scale of 0-10 (0=not at all; 10=most severe)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GVS Entire Session, GVS From Mid-Session, Then No GVS', 'description': 'Subjects received Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from beginning for experimental visit 1; subjects received GVS ON from mid-session in the rotating chair for experimental visit 2; subjects received GVS stimulation OFF for entire session in rotating chair for experimental visit 3.\n\nGalvanic Vestibular Stimulation: Low electrical currents to the vestibular system, to induce the realistic sensation of motion (i.e., the g-forces that occur during flight) as well as null out motion perception.'}, {'id': 'FG001', 'title': 'GVS Entire Session, No GVS, Then GVS From Mid-Session', 'description': 'Subjects received Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from beginning for experimental visit 1; subjects received GVS stimulation OFF for entire session in rotating chair for experimental visit 2; subjects received GVS ON from mid-session in the rotating chair for experimental visit 3.\n\nGalvanic Vestibular Stimulation: Low electrical currents to the vestibular system, to induce the realistic sensation of motion (i.e., the g-forces that occur during flight) as well as null out motion perception.'}, {'id': 'FG002', 'title': 'GVS From Mid-Session, GVS Entire Session, Then No GVS', 'description': 'Subjects received Galvanic Vestibular Stimulation (GVS) ON from mid-session in the rotating chair for experimental visit 1; subjects received GVS to mitigate motion sickness in the rotating chair turning stimulation ON from beginning for experimental visit 2; subjects received GVS stimulation OFF for entire session in rotating chair for experimental visit 3.\n\nGalvanic Vestibular Stimulation: Low electrical currents to the vestibular system, to induce the realistic sensation of motion (i.e., the g-forces that occur during flight) as well as null out motion perception.'}, {'id': 'FG003', 'title': 'GVS From Mid-Session, No GVS, Then GVS Entire Session', 'description': 'Subjects received Galvanic Vestibular Stimulation (GVS) ON from mid-session in the rotating chair for experimental visit 1; subjects received GVS stimulation OFF for entire session in rotating chair for experimental visit 2; subjects received GVS to mitigate motion sickness in the rotating chair turning stimulation ON from beginning for experimental visit 3.\n\nGalvanic Vestibular Stimulation: Low electrical currents to the vestibular system, to induce the realistic sensation of motion (i.e., the g-forces that occur during flight) as well as null out motion perception.'}, {'id': 'FG004', 'title': 'No GVS, GVS From Mid-Session, Then GVS Entire Session', 'description': 'Subjects received Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation OFF from beginning for experimental visit 1; subjects received GVS ON from mid-session in the rotating chair for experimental visit 2; subjects received GVS stimulation ON for entire session in rotating chair for experimental visit 3.\n\nGalvanic Vestibular Stimulation: Low electrical currents to the vestibular system, to induce the realistic sensation of motion (i.e., the g-forces that occur during flight) as well as null out motion perception.'}, {'id': 'FG005', 'title': 'No GVS, GVS Entire Session, Then GVS From Mid-Session', 'description': 'Subjects received Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation OFF from beginning for experimental visit 1; subjects received GVS stimulation ON for entire session in rotating chair for experimental visit 2; subjects received GVS ON from mid-session in the rotating chair for experimental visit 3.\n\nGalvanic Vestibular Stimulation: Low electrical currents to the vestibular system, to induce the realistic sensation of motion (i.e., the g-forces that occur during flight) as well as null out motion perception.'}], 'periods': [{'title': 'First Experimental Visit (1.5 Hour)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second Experimental Visit (1.5 Hour)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Third Experimental Visit (1.5 Hour)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Total of 29 participants were enrolled to receive all interventions, however the order the intervention was received was randomized. All subjects completed the first experimental visit. 2 subjects withdrew from the study prior to the start of the second experimental visit.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Galvanic Vestibular Stimulation', 'description': 'Subjects attend four visits of the experiment on four separate days. Each visit will be an hour and a half long. In the first visit, subjects will perform batteries of tests that involve balance, cognition, and determine motion perception at different current levels using a rotating chair. In the next three visits, researchers will test the Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair be either turning stimulation ON from beginning, or middle or by not turning ON (the order will be randomized).\n\nGalvanic Vestibular Stimulation: Low electrical currents to the vestibular system, to induce the realistic sensation of motion (i.e., the g-forces that occur during flight) as well as null out motion perception.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '32', 'spread': '9.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-04', 'size': 505751, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-30T15:31', 'hasProtocol': True}, {'date': '2022-08-24', 'size': 4606841, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-09-07T11:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Subjects attend four visits of the experiment on four separate days. Each visit will be an hour and a half long. In the first visit, subjects will perform batteries of tests that involve balance, cognition, and determine motion perception at different current levels using a rotating chair. In the next three visits, researchers will test the Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair be either turning stimulation ON from beginning, or middle or by not turning ON (the order will be randomized).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2021-04-01', 'resultsFirstSubmitDate': '2023-06-14', 'studyFirstSubmitQcDate': '2021-04-23', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-27', 'studyFirstPostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motion Perception', 'timeFrame': 'During the rotation of the chair, approximately 1 hr', 'description': 'Motion Perception verbal report using a visual analog scale (1-100) will be recorded during the rotation of the chair (1=feeling no motion perception; 100=feeling the maximum motion perception)'}], 'secondaryOutcomes': [{'measure': 'Motion Sickness Questionnaire', 'timeFrame': 'During the rotation of the chair, approximately 1 hr', 'description': 'subjective experiences of motion sickness in a scale of 0-10 (0=not at all; 10=most severe)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is evaluate the effect of timing and magnitude on the administration of our nonpharmaceutical treatment to motion sickness, and to evaluate the effect of Galvanic Vestibular Stimulation (GVR) amplitude on functional fitness task performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be able to consent to participate themselves.\n* Must be able to attend in-person sessions at the Mayo Aerospace Medicine and Vestibular Research Laboratory in Scottsdale, AZ.\n* No racial ethnic groups will be excluded.\n* Must be fluent speakers of English.\n\nExclusion Criteria:\n\n* History of vestibular disease, migraine, or significant balance disorder.\n* Traumatic brain injury.\n* Recent middle ear infection or recent motion sickness (within 72 hours).\n* History of severe motion sensitivity.\n* Women who are pregnant.'}, 'identificationModule': {'nctId': 'NCT04859868', 'briefTitle': 'Non-pharmaceutical Motion Sickness Mitigation', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Non-pharmaceutical Motion Sickness Mitigation', 'orgStudyIdInfo': {'id': '20-005763'}, 'secondaryIdInfos': [{'id': '80NSSC21K0175', 'type': 'OTHER_GRANT', 'domain': 'National Aeronautics and Space Administration'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Galvanic Vestibular Stimulation During the Entire Session', 'description': 'Subjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from beginning.', 'interventionNames': ['Device: Galvanic Vestibular Stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'No Galvanic Vestibular Stimulation', 'description': 'Subjects were not given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation entire session.'}, {'type': 'EXPERIMENTAL', 'label': 'Galvanic Vestibular Stimulation Starting From Mid-session', 'description': 'Subjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from the middle of the session.', 'interventionNames': ['Device: Galvanic Vestibular Stimulation']}], 'interventions': [{'name': 'Galvanic Vestibular Stimulation', 'type': 'DEVICE', 'description': 'Low electrical currents to the vestibular system, to induce the realistic sensation of motion (i.e., the g-forces that occur during flight) as well as null out motion perception.', 'armGroupLabels': ['Galvanic Vestibular Stimulation During the Entire Session', 'Galvanic Vestibular Stimulation Starting From Mid-session']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Gaurav N Pradhan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gaurav N. Pradhan', 'investigatorAffiliation': 'Mayo Clinic'}}}}