Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-18 @ 4:01 AM
Study NCT ID:
NCT02201927
Status:
TERMINATED
Last Update Posted:
2015-02-03
First Post:
2014-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stimulation Galvanique Vestibulaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'lack of performance', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-02', 'studyFirstSubmitDate': '2014-07-22', 'studyFirstSubmitQcDate': '2014-07-24', 'lastUpdatePostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'deviation from target score', 'timeFrame': '30 min', 'description': 'difference in degree between the actual and target score'}], 'secondaryOutcomes': [{'measure': 'deviation from target "straight ahead"', 'timeFrame': '30min', 'description': 'difference in degree between the actual straight ahead and target score'}, {'measure': 'deviation rightward line bisection', 'timeFrame': '30min', 'description': 'percentage difference between actual and target score on test "deviation right line bisection"'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['galvanic vestibular stimulation', 'right parietal lobe lesion', 'egocentric space'], 'conditions': ['Hypertensive Hemorrhage of Right Parietal Lobe']}, 'descriptionModule': {'briefSummary': 'Right posterior parietal cortex is involved in spatial cognition. Blindfolded patients suffering right posterior parietal lesions fail to update their own position after a body rotation. Right cathodal galvanic vestibular stimulation activates right posterior parietal cortex and reduces symptoms of spatial neglect, another disability frequently encountered after right posterior parietal lesion. The aims of this study are to confirm posterior parietal involvement in automatic updating of body-centered spatial relationships and to evaluate therapeutic effects of galvanic vestibular stimulation. Performances of three groups of adults are compared before and during galvanic vestibular stimulation on a pointing task: a healthy control group, a brain-injured control group with stroke lesions sparing right posterior parietal cortex and a group of stroke patients with right posterior parietal lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patient with right posterieur parietal lobe lesion\n* patient with cerebral vascular stroke\n* healthy volonteers Age greater than or equal to 18 written informed consent\n\nExclusion Criteria:\n\n* patient's refusal to participate to the study\n* inability to cooperate\n* cognitive trouble\n* epilepsy"}, 'identificationModule': {'nctId': 'NCT02201927', 'acronym': 'GVS', 'briefTitle': 'Stimulation Galvanique Vestibulaire', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Investigation Clinique et Technologique 805"}, 'officialTitle': 'Galvanic Vestibular Stimulation : Role in the Improvement of Egocentric Frame in Patient With Right Parietal Lobe Lesions', 'orgStudyIdInfo': {'id': '2013-A01243-42/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patient with right parietal lobe lesion', 'description': 'Patient with right parietal lobe lesion', 'interventionNames': ['Device: galvanic vestibular stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'patient stroke', 'description': 'patient with cerebral vascular accident', 'interventionNames': ['Device: galvanic vestibular stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'healthy volunteers', 'description': 'healthy volunteers', 'interventionNames': ['Device: galvanic vestibular stimulation']}], 'interventions': [{'name': 'galvanic vestibular stimulation', 'type': 'DEVICE', 'otherNames': ['deviation from target score with and without galvanic vestibular stimulation'], 'armGroupLabels': ['healthy volunteers', 'patient stroke', 'patient with right parietal lobe lesion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'state': 'Garches', 'country': 'France', 'facility': 'Hopital Raymond Poincare Mpr', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'overallOfficials': [{'name': 'Ruet Alexis, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HOPITAL RAYMOND POINCARE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Investigation Clinique et Technologique 805", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Versailles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}