Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-31 @ 11:36 AM
Study NCT ID:
NCT06704360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-26
First Post:
2024-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009788', 'term': 'Occupational Therapy'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-23', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2024-11-23', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mental State Examination Scale (MMSE)', 'timeFrame': '1. finished in 3 days before training. 2. finished 3 days after 30-days training', 'description': 'Global cognitive function assessment. Easy to use and one of the most used scales to screen person with cognitive impairment in the world. The minimum and maximum values range from 0 to 30. Higher score means better cognition level.'}, {'measure': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': '1. finished in 3 days before training. 2. finished 3 days after 30-days training', 'description': 'one of the most used scales to assess cognition and screen person with cognitive impairment in the world. The minimum and maximum values range from 0 to 30. Higher score means better cognition level.'}, {'measure': 'Brain functional activation (fNIRS)', 'timeFrame': '1. finished in 3 days before training. 2. finished 3 days after 30-days training', 'description': 'Brain functional activation of each patient during the cognitive task (Stroop task, 1-back task and verbal fluency test) will be evaluated using functional near-infrared spectroscopy (fNIRS).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'virtual reality', 'fNIRS', 'cognitive impairment'], 'conditions': ['Stroke', 'Cognitive Decline']}, 'descriptionModule': {'briefSummary': 'This is a single-blind randomized controlled trial to evaluate the efficacy and safety of immersive virtual reality for post-stroke cognitive impairment.', 'detailedDescription': "This is a single-blind randomized controlled intervention study. Each stroke subject will undergo screening period, baseline assessment period, intervention period, endpoint assessment period.\n\nIn the screening period, the verification of inclusion/exclusion criteria and the acquisition of informed consent will be completed.\n\nIn the baseline assessment period and endpoint assessment period, 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. Meanwhile, brain functional activation of each patient during the cognitive task (Stroop task, 1-back task and verbal fluency test) will be evaluated using functional near-infrared spectroscopy (fNIRS).\n\nIn the intervention period, the VR group will receive immersive VR cognitive training with suitable for training intensity and the control group will receive the conventional cognitive train (occupational therapy) with suitable for training intensity in the control group. The training will lasted 20 minutes per time, 5 times per week for four weeks, with a total of 600 minutes, training frequency will be adjusted according to the patient's own conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of stroke by neuroimaging (CT or MRI) assessment\n2. 18-85 years old\n3. Be able to follow instructions to complete the test\n4. Can tolerate the rehabilitation training of this experiment\n5. First stroke\n6. Patients who signed informed consent\n\nExclusion Criteria:\n\n1. The test could not be tolerated due to organic disease\n2. There is a serious mental illness resulting in inability to cooperate with or tolerate this test\n3. is participating in another clinical trial involving an investigational drug or physical therapy\n4. Patients who have not signed informed consent'}, 'identificationModule': {'nctId': 'NCT06704360', 'acronym': 'EVRPSC', 'briefTitle': 'Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'A Single-blind Randomized Controlled Trial to Evaluate Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment', 'orgStudyIdInfo': {'id': '20241120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR group (virtual reality cognitive training group)', 'description': 'Immersive VR cognitive training with suitable training intensity.', 'interventionNames': ['Device: immersive VR pathfinding training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OT group (occupational therapy group)', 'description': 'Conventional cognitive training (occupational therapy) with suitable training intensity.', 'interventionNames': ['Other: Occupational therapy']}], 'interventions': [{'name': 'immersive VR pathfinding training', 'type': 'DEVICE', 'description': 'Pathfinding training with immersive VR.', 'armGroupLabels': ['VR group (virtual reality cognitive training group)']}, {'name': 'Occupational therapy', 'type': 'OTHER', 'description': 'Only receive conventional cognitive training group', 'armGroupLabels': ['OT group (occupational therapy group)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dingqun Bai', 'role': 'CONTACT', 'email': 'baidingqun2014@163.com', 'phone': '023-89011334'}, {'name': 'Defei Chen', 'role': 'CONTACT', 'email': '2283273437@qq.com', 'phone': '+8615188017034'}], 'overallOfficials': [{'name': 'Dingqun Bai', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Chongqing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}}}}