Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-29 @ 5:02 AM
Study NCT ID:
NCT06270966
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Remediation VR Tool for People With MCI: a Feasibility RCT
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2024-02-13', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Side effects; Dropout rates; Proportion of recruited participants among those considered eligible', 'timeFrame': 'T0 (0 weeks); T1 (12 weeks)', 'description': 'Feasibility will be assessed based on tolerability, including dropout rates and acceptability, which considers the proportion of recruited participants among those considered eligible and side effects.'}], 'secondaryOutcomes': [{'measure': 'Short Form Health Survey, 12 items (SF-12)', 'timeFrame': 'T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)', 'description': 'Preliminary measures of effectiveness on quality of life, 12 items'}, {'measure': 'Brief Social Rhythms Scale (BSRS)', 'timeFrame': 'T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)', 'description': 'Preliminary measures of effectiveness on biological and social rhythms, 10 items'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)', 'description': 'Preliminary measures of effectiveness on depressive symptoms, 9 Items'}, {'measure': 'Generalized Anxiety Disorder-7 item (GAD-7)', 'timeFrame': 'T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)', 'description': 'Preliminary measures of effectiveness on anxiety, 7 items'}, {'measure': "Addenbrooke's Cognitive Examination (ACE-R)", 'timeFrame': 'T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)', 'description': 'Preliminary measures of effectiveness on general cognitive functions, the neuropsychological tests is used to identify cognitive impairment in conditions such as dementia.'}, {'measure': 'Matrix test', 'timeFrame': 'T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)', 'description': 'Preliminary measures of effectiveness on attention'}, {'measure': "Rey's Word Test", 'timeFrame': 'T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)', 'description': 'Preliminary measures of effectiveness on memory'}, {'measure': 'Trail Making Test (TMT)', 'timeFrame': 'T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)', 'description': 'Preliminary measures of effectiveness on executive function'}, {'measure': 'Digit Span', 'timeFrame': 'T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)', 'description': 'Preliminary measures of effectiveness on memory'}, {'measure': 'Stroop Test', 'timeFrame': 'T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)', 'description': 'Preliminary measures of effectiveness on executive function'}, {'measure': 'Frontal Assessment Battery (FAB)', 'timeFrame': 'T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)', 'description': 'Preliminary measures of effectiveness on executive function'}, {'measure': 'Cognitive Estimates Test (CET)', 'timeFrame': 'T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)', 'description': 'Preliminary measures of effectiveness on executive function'}, {'measure': 'Rey Figure Test', 'timeFrame': 'T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)', 'description': 'Preliminary measures of effectiveness on visual spatial function'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment', 'Cognitive Remediation', 'Virtual Reality', 'Psychiatric Rehabilitation']}, 'descriptionModule': {'briefSummary': 'The need to promote research in active aging trough multidisciplinary and innovative approaches is strongly indicated by the European Union. Our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (VR) technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI)', 'detailedDescription': 'The European Union emphasizes the need to promote research in active aging trough multidisciplinary and innovative approaches, addressing challenges related to neurodegenerative diseases in old adults. Our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (VR) technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI).\n\nMethods: A feasibility randomized controlled clinical trial will involve 30 individuals who are over 65 years old, both sex, who have received the diagnosis of MCI, randomly assigned to experimental condition or control group. Both groups will continue to receive standard pharmacological therapy (TAU). The experimental group will undergo a 3-months cognitive remediation program with fully immersive VR with two sessions per week (each session of sixty minutes). The control group will continue with TAU.\n\nFeasibility will be assessed based on tolerability, including dropout rates and acceptability, (proportion of recruited participants among those considered eligible) and side effects. The preliminary measures of effectiveness will be evaluated on cognitive functions, quality of life, biological and social rhythms, anxiety and depressive.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 65 and above, a diagnosis of MCI based on DSM-IV criteria \\[American Psychiatric Association, 2000\\]\n\nExclusion Criteria:\n\n* failure to meet inclusion criteria, a diagnosis of epilepsy or severe visual impairments due to potential risks associated with extensive virtual reality stimulation, and severe illnesses impeding bi-weekly intervention attendance'}, 'identificationModule': {'nctId': 'NCT06270966', 'briefTitle': 'Cognitive Remediation VR Tool for People With MCI: a Feasibility RCT', 'organization': {'class': 'OTHER', 'fullName': 'University of Cagliari'}, 'officialTitle': 'Cognitive Remediation Virtual Reality Tool a Recovery-oriented Project for People With Mild Cognitive Impairment: a Feasibility Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '28287 08/11/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Cognitive Remediation + treatment as usual', 'description': '15 Participants with more than 65 years and with MCI diagnosis will undergo a cognitive remediation program using fully immersive VR. Participants will continue with standard care during the experimental intervention', 'interventionNames': ['Device: Virtual Reality Cognitive Remediation']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': 'The control group, 15 participants with more than 65 years and with MCI diagnosis, will continue with standard care.'}], 'interventions': [{'name': 'Virtual Reality Cognitive Remediation', 'type': 'DEVICE', 'description': 'Participants will undergo a 3-months cognitive remediation program using fully immersive VR with two sessions per week. Each session will last a maximum of sixty minutes and will be supervised by expert health professionals. The experimental group participated in an immersive VR-based CR program using the "CEREBRUM" software designed by clinicians and experts specializing in cognitive rehabilitation.\n\nCEREBRUM provides 52 exercises: Attention, Working Memory, Memory and Learning and Cognitive Estimates. The intervention included 24 sessions.', 'armGroupLabels': ['Virtual Reality Cognitive Remediation + treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09100', 'city': 'Cagliari', 'state': 'CA', 'country': 'Italy', 'facility': 'San Giovanni di Dio Hospital', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cagliari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mauro Giovanni Carta', 'investigatorAffiliation': 'University of Cagliari'}}}}