Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT04288505
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2020-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Virtual Reality Tool for Identifying the Cognitive Functions of the Right Hemisphere in Patients With Brain Damage -TANGO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance of the virtual reality application compared to classic cognitive tests batery for the detection of cognitive deficit', 'timeFrame': 'from surgery to 3 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Performance of the virtual reality application compared with conventional cognitive tests used to detect visual-spatial attention disorders', 'timeFrame': 'from surgery to 3 months after surgery'}, {'measure': 'Performance of the virtual reality application compared with conventional cognitive tests used to detect facial emotion recognition disorders', 'timeFrame': 'from surgery to 3 months after surgery'}, {'measure': 'Performance of the virtual reality application compared with conventional cognitive tests, used to detect spatial attention disorders or the presence of facial emotion recognition disorders depending respectively on the location or type of facial emotion', 'timeFrame': 'from surgery to 3 months after surgery'}, {'measure': 'Study the reproducibility of the virtual reality application for detecting the presence of cognitive function disorders', 'timeFrame': 'from surgery to 3 months after surgery'}, {'measure': 'Study the correlation between visuo-spatial and facial emotion recognition deficits and possible tractographic changes', 'timeFrame': 'from surgery to 3 months after surgery'}, {'measure': 'Study the association between the presence of cognitive function deficits and the presence of behavioral disorders or health-related quality of life', 'timeFrame': 'from surgery to 3 months after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Virtual Reality', 'Brain Damage']}, 'descriptionModule': {'briefSummary': 'Evaluate the diagnostic performance of a virtual reality application to detect the presence of cognitive impairment of the non-dominant hemisphere in patients with brain damage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for brain lesion located in the right hemisphere surgery\n* Major patient\n* Karnofsky ≥ 70\n\nExclusion Criteria:\n\n* Person with aphasia\n* Person with visual problems\n* Person with a contraindication to MRI\n* Person unable to carry out the tests planned in the study'}, 'identificationModule': {'nctId': 'NCT04288505', 'acronym': 'TANGO', 'briefTitle': 'Evaluation of a Virtual Reality Tool for Identifying the Cognitive Functions of the Right Hemisphere in Patients With Brain Damage -TANGO', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Evaluation of a Virtual Reality Tool for Identifying the Cognitive Functions of the Right Hemisphere in Patients With Brain Damage -TANGO', 'orgStudyIdInfo': {'id': '2020-A00074-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single arm', 'interventionNames': ['Diagnostic Test: VIRTUAL REALITY application']}], 'interventions': [{'name': 'VIRTUAL REALITY application', 'type': 'DIAGNOSTIC_TEST', 'description': 'application on virtual reality headset', 'armGroupLabels': ['single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}