Ignite Creation Date:
2025-12-25 @ 1:59 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT06380894
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2024-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Cognitive Training for Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-27', 'size': 384298, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-15T09:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2024-04-10', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Memory Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtests at Week 11', 'timeFrame': 'Baseline and Week 11', 'description': 'The RBANS is a comprehensive neuropsychological battery that has been validated with local norms in Singapore. Its subtests of List Learning, List Recall and List Recognition measures verbal memory while Picture Copy and Picture Recall measures visual memory. It is administered by trained clinical research coordinators and scored by neuropsychologists. Raw scores of each subtests are compared.'}, {'measure': 'Change from Baseline in Attention Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest at Week 11', 'timeFrame': 'Baseline and Week 11', 'description': 'The RBANS is a comprehensive neuropsychological battery that has been validated with local norms in Singapore. Its subtest of Digit Span measures attention. It is administered by trained clinical research coordinators and scored by neuropsychologists. Raw scores of the Digit Span subtest is compared.'}, {'measure': 'Change from Baseline in Attention Performance on the Colour Trails Test 1 at Week 11', 'timeFrame': 'Baseline and Week 11', 'description': 'The Colour Trails Test 1 requires the respondent to connect circles in an ascending numbered sequence. Time taken to complete each part of the CTT is recorded in seconds.'}, {'measure': 'Change from Baseline in Executive Function Performance on the Frontal Assessment Battery (FAB) at Week 11', 'timeFrame': 'Baseline and Week 11', 'description': "The FAB is a short screening tests used to evaluate executive function. Its components consist of S-word generation, similarities, Luria's test, grasp reflex, and the Go-No-Go test. The sum of the sub-scores from each of the six components are added up to generate total score out of 18."}, {'measure': 'Change from Baseline in Executive Function Performance on the Colour Trails Test 2 at Week 11', 'timeFrame': 'Baseline and Week 11', 'description': "The FAB is a short screening tests used to evaluate executive function. Its components consist of S-word generation, similarities, Luria's test, grasp reflex, and the Go-No-Go test. The sum of the sub-scores from each of the six components are added up to generate total score out of 18."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the feasibility and efficacy of a 10-weekly multi-domain VRCT program on the cognitive function (i.e. attention, memory, and executive functioning) of older adults with MCI.', 'detailedDescription': 'This study employed a pilot feasibility parallel design approach. Participants were randomly assigned to either the VRCT intervention group or the active control group. The outcome assessor was blinded. Participants were recruited from outpatient clinics in Changi General Hospital, Singapore. They were referred by treating geriatricians and psycho-geriatricians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* aged 65-85\n* diagnosis of MCI by a clinician in accordance to Petersen's criteria\n* MMSE ≥ 23\n* ability to see and hear\n* ability to read and write in either English or Mandarin\n\nExclusion Criteria:\n\n* diagnosed with a primary other neurocognitive disorder\n* diagnosed with major psychiatric illness such as major depressive disorder or anxiety disorder, severe visual or auditory impairment\n* diagnosed with serious medical illnesses including acute or severe asthma, severe or unstable cardiovascular disease, active gastric ulcer, severe liver disease or severe renal disease."}, 'identificationModule': {'nctId': 'NCT06380894', 'briefTitle': 'Virtual Reality Cognitive Training for Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Changi General Hospital'}, 'officialTitle': 'Virtual Reality Cognitive Training for Mild Cognitive Impairment - A Pilot Feasibility Study', 'orgStudyIdInfo': {'id': '2020/2239'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Cognitive Training', 'description': 'The program consisted of two components: (1) psychoeducation on cognitive functioning and ways to maintain cognitive health, (2) VR multi-domain cognitive training tasks that target cognitive domains of attention, memory, and executive functioning.', 'interventionNames': ['Device: Virtual Reality Cognitive Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Control Group', 'description': 'Participants who were assigned to the active control group were provided treatment-as-usual, which included: (1) psychoeducation on MCI, cognitive functioning, and compensatory strategies, and (2) brain training cognitive stimulation booklet which consisted of weekly homework activities focusing on attention, memory, and executive functioning. Control participants were reviewed for 3 sessions monthly to follow up on their progress on the cognitive stimulation activity booklet.', 'interventionNames': ['Behavioral: Active Control']}], 'interventions': [{'name': 'Virtual Reality Cognitive Training', 'type': 'DEVICE', 'description': 'Participants who were assigned to the VRCT intervention group underwent 60 minutes of weekly VRCT sessions over a 10-week intervention period. The program consisted of two components: (1) psychoeducation on cognitive functioning and ways to maintain cognitive health, (2) VR multi-domain cognitive training tasks that target cognitive domains of attention, memory, and executive functioning.\n\nThe VR experiences were administered through a head-mounted Oculus Go Screen V7. The VR system runs on a software developed by Dancing Mind Pte Ltd. The software specifications and service provided by Dancing Mind Pte Ltd include: MindGym System Functions: System Setup (Processor Setup, Password Changing etc) and Data Centre (Memory Care Therapy Data Analytics Report Querying and Printing Functions). The MindGym cognitive training content was developed based on the Singaporean culture, with visual stimuli reflecting familiar local environments.', 'armGroupLabels': ['Virtual Reality Cognitive Training']}, {'name': 'Active Control', 'type': 'BEHAVIORAL', 'description': 'Participants who were assigned to the active control group were provided treatment-as-usual, which included: (1) psychoeducation on MCI, cognitive functioning, and compensatory strategies, and (2) brain training cognitive stimulation booklet which consisted of weekly homework activities focusing on attention, memory, and executive functioning. Control participants were reviewed for 3 sessions monthly to follow up on their progress on the cognitive stimulation activity booklet.', 'armGroupLabels': ['Active Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Zhong Jie Zaylea Kua, MPsychClin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changi General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}