Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT06703320
Status:
RECRUITING
Last Update Posted:
2024-11-26
First Post:
2024-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brain Activation Pattern Caused by Immersive Virtual Reality Pathfinding Task in Stroke Patients: an FNIRS Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-23', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2024-11-21', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain Activation Pattern Caused by Immersive Virtual Reality Pathfinding Task in Stroke Patients', 'timeFrame': '1 day', 'description': 'Comparison of differences in brain activation \\[HbO2 (mmol/L\\*mm)\\] between patients with post-stroke cognitive impairment and patients without post-stroke cognitive impairment or healthy subjects during Immersive Virtual Reality Pathfinding Task.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'virtual reality', 'cognitive impairment', 'fNIRS'], 'conditions': ['Stroke', 'Cognitive Decline']}, 'descriptionModule': {'briefSummary': 'This is an fNIRS study performed to investigate Brain Activation Pattern Caused by Immersive Virtual Reality Pathfinding Task in Stroke Patients.', 'detailedDescription': 'This was an initial screening and preliminary intervention study. Both healthy subject and stroke patients will be included in this study. Brain functional activation of each subject during Immersive Virtual Reality Pathfinding Task will be evaluated using functional near-infrared spectroscopy (fNIRS). Cognitive function related scale assessment included Mental State Examination Scale (MMSE), Montreal Cognitive Assessment (MoCA), drawing clock test (DCT), Shape trials test A.B (STT-A, STT-B), standardized digital modal test (SDMT), auditory verbal learning test-Huashan version (AVLT-H), and activity of daily living (ADL) scale will be used to evaluate the function of each patient. Brain Activation Pattern Caused by Immersive Virtual Reality Pathfinding Task will be identified by by comparing differences in brain activation and brain network connectivity between patients and healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stroke in the inpatient ward of the Department of Rehabilitation Medicine, The First Affiliated Hospital of Chongqing Medical University.\n\nHealthy subjects recruited through the Department of Rehabilitation Medicine, The First Affiliated Hospital of Chongqing Medical University.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStroke patients:\n\n1. Diagnosis of stroke confirmed by neuroimaging (CT or MRI)\n2. 18-80 years old\n3. Able to complete the cognitive task\n4. Able to follow instructions to complete the trial\n5. Patients who signed an informed consent form.\n\nHealthy Subjects:\n\n1. No abnormalities on cranial\n2. 18-80 years old\n3. Able to complete cognitive task\n4. Able to follow instructions to complete the trial\n5. not taking medications.\n6. Subjects who signed an informed consent form.\n\nExclusion Criteria:\n\nStroke patients:\n\n1. Inability to tolerate the test due to organic diseases\n2. Serious mental illness that prevents them from cooperating with or tolerating the trial\n3. Pregnant or lactating women\n4. Had metal implants, a history of other neurological disorders, acute cardiopulmonary dysfunction.\n\nHealthy Subjects:\n\n1. Inability to tolerate the test due to organic diseases\n2. Serious mental illness that prevents them from cooperating with or tolerating the trial.\n3. Pregnant or lactating women\n4. Had metal implants, a history of other neurological disorders, acute cardiopulmonary dysfunction'}, 'identificationModule': {'nctId': 'NCT06703320', 'briefTitle': 'Brain Activation Pattern Caused by Immersive Virtual Reality Pathfinding Task in Stroke Patients: an FNIRS Study', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Brain Activation Pattern Caused by Immersive Virtual Reality Pathfinding Task in Stroke Patients: a Functional Near-infrared Spectroscopy Study', 'orgStudyIdInfo': {'id': '20241122'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy subjects', 'description': 'Healthy subjects without history of stroke or cognitive impairment.'}, {'label': 'PSCI', 'description': 'Healthy subjects without history of stroke or cognitive impairment.'}, {'label': 'NPSCI', 'description': 'Stroke patients without post-stroke cognitive impairment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '400010', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Defei Chen', 'role': 'CONTACT', 'email': '2283273437@qq.com', 'phone': '+8615188017034'}], 'facility': 'Department of Rehabilitation Medicine, the First Affiliated Hospital of Chongqing Medical University, Chongqing,, Chongqing, Chongqing 400010', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Dingqun Bai', 'role': 'CONTACT', 'email': 'baidingqun@hospital.cqmu.edu.cn', 'phone': '023-89011334'}, {'name': 'Defei Chen', 'role': 'CONTACT', 'email': '2283273437@qq.com', 'phone': '+8615188017034'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dingqun Bai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of rehabilitation Medicine', 'investigatorFullName': 'Dingqun Bai', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}