Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-28 @ 12:06 AM
Study NCT ID:
NCT06838494
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-20
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Immersive Virtual Reality for Cognitive Therapy in Elderly with 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-17', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hong Kong Montreal Cognitive Assessment (HK-MoCA)', 'timeFrame': 'From 1-week pre-intervention to 13 weeks post-intervention', 'description': 'Hong Kong Montreal Cognitive Assessment (HK-MoCA) Measurement of global cognition in participants, covering various cognitive domains such as visuo-spatial skills, executive functions, attention, memory, language, and orientation. The total score ranges from 1-30, with higher score indicating better performance.'}, {'measure': 'Digit Span Forward and Backward Tasks', 'timeFrame': 'From 1-week pre-intervention to 13 weeks post-intervention', 'description': 'Assessment of working memory capacity, predicting progression from MCI to dementia. The test will start from 1 digit with increasing number of digit to increase level of difficulty.'}, {'measure': 'Verbal Fluency of Semantic Category', 'timeFrame': 'From 1-week pre-intervention to 13 weeks post-intervention', 'description': 'Evaluation of semantic integrity, cognitive flexibility, and executive function by measuring the number of items correctly produced in one minute across different semantic categories (animals, fruits, transportation).'}], 'secondaryOutcomes': [{'measure': 'Chinese Version of the Modified Barthel Index', 'timeFrame': 'From 1-week pre-intervention to 13 weeks post-intervention', 'description': 'Assessment of the level of independence in activities of daily living, including grooming, feeding, mobility, toileting, and more. The test score ranges from 1-100 with higher scores indicating better performance.'}, {'measure': 'Hong Kong Lawton Instrumental Activities of Daily Living Scale', 'timeFrame': 'From 1-week pre-intervention to 13 weeks post-intervention', 'description': 'Evaluation of independence in performing community-living skills, such as cooking, household management, and shopping. The test score ranged from 0-18 and a higher score indicates better performance.'}, {'measure': "Feasibility Outcomes and Users' Experience", 'timeFrame': 'Throughout the intervention period (from weeks 1-7 of intervention)', 'description': 'Objective measures of feasibility, including the number of adverse events and technical issues during the intervention, as well as adherence to the intervention protocol (actual duration and number of sessions conducted vs. scheduled).'}, {'measure': 'Semi-Structured Interview for IVR-CST Group', 'timeFrame': 'Immediately post-intervention', 'description': 'Post-therapy interview assessing comfort levels, presence of adverse effects (e.g., cybersickness), and the impact of therapy on daily functions. Conducted by a trained research assistant in a quiet clinical room, with the session audio-taped.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mild Cognitive Impairment (MCI)', 'Cognitive stimulation therapy', 'immersive reality', 'Eye-tracking'], 'conditions': ['Mild Cognitive Impairment (MCI)']}, 'referencesModule': {'references': [{'pmid': '40857307', 'type': 'DERIVED', 'citation': 'Wong WWS, Wong GHY, Choy JCP, Pui Li DS, Lo YL. Utilization of Immersive Virtual Reality in Cognitive Stimulation Therapy (IVR-CST) for elderly with mild cognitive impairment: A randomized controlled pilot study protocol. PLoS One. 2025 Aug 26;20(8):e0330686. doi: 10.1371/journal.pone.0330686. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'The proposed study aims to investigate the potential of IVR-CST in improving cognition of people with MCI, and as well the association of eye movement during therapy and treatment outcomes of IVR-CST. Four research questions have been proposed and listed as follows:\n\n1. Is IVR-CST a feasible treatment for elderly with MCI?\n2. Is IVR-CST an efficacious treatment for improving cognition of elderly with MCI?\n3. Is IVR-CST more efficacious than conventional CST (i.e., without IVR) in improving the cognition of elderly with MCI?\n4. Is eye-tracking data collected during therapy associated with treatment outcomes of IVR CST?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. elderly aged 60 years or above,\n2. a diagnosis of MCI made by a psychiatrist, or a score of 16-21 out of 30 in the Hong Kong Brief Cognitive Test (HKBC, 31), with upper and lower cutoff scores for MCI as suggested by the test. HKBC has been validated in Hong Kong with satisfactory sensitivity (0.88) and specificity ((0.81) in differentiating subjects with MCI and healthy individuals,\n3. ability to speak and comprehend Cantonese,\n4. normal or corrected-to-normal binocular vision and hearing,\n5. absence of physical illness/disability to prevent them from IVR-CST participation, 6, compatible with IVR exposure in the 10-minute IVR trial without major signs of cybersickness, based on the symptoms given in the Simulator Sickness Questionnaire\n\nExclusion Criteria:\n\n1. concurrent participation in other clinical therapy trials,\n2. incompatibility with IVR exposure such as complaints of nausea, headache, or other severe discomforts during trial use,\n3. a diagnosis of dementia or other psychiatric/neurological diseases such as depression, stroke, brain trauma, Parkinson's disease\n4. hearing/visual/upper limb impairments that hinder CST/IVR-CST participation,\n5. prior CST treatment,\n6. Use of medication for MCI/dementia, e.g., aducanumab"}, 'identificationModule': {'nctId': 'NCT06838494', 'acronym': 'VR-CST-MCI', 'briefTitle': 'Using Immersive Virtual Reality for Cognitive Therapy in Elderly with Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Utilization of Immersive Virtual Reality in Cognitive Stimulation Therapy (IVR-CST) for Elderly with Mild Cognitive Impairment: a Randomized Controlled Pilot Study', 'orgStudyIdInfo': {'id': 'HSEARS20241010009'}, 'secondaryIdInfos': [{'id': '22231471', 'type': 'OTHER_GRANT', 'domain': 'Health and Medical Research Fund'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IVR-CST Group', 'interventionNames': ['Behavioral: IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional CST Group', 'interventionNames': ['Behavioral: Intervention Name: Conventional CST (Cognitive Stimulation Therapy)']}], 'interventions': [{'name': 'IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy)', 'type': 'BEHAVIORAL', 'description': 'IVR-CST involves 14 sessions of cognitive stimulation therapy conducted twice a week in a virtual reality environment. Each session lasts approximately 45 minutes and utilizes head-mounted displays (HMDs) to immerse participants in engaging, themed activities. The therapy aims to enhance cognitive function and social interaction through interactive and stimulating virtual experiences tailored for individuals with mild cognitive impairment (MCI).', 'armGroupLabels': ['IVR-CST Group']}, {'name': 'Intervention Name: Conventional CST (Cognitive Stimulation Therapy)', 'type': 'BEHAVIORAL', 'description': 'Conventional CST consists of 14 sessions of cognitive stimulation therapy conducted twice a week, each lasting about 45 minutes. In this arm, participants engage in group activities using physical materials, such as photos, pictures, and real objects, rather than virtual reality. The therapy focuses on providing cognitive stimulation through discussions and activities designed to improve cognitive function and social engagement among individuals with mild cognitive impairment (MCI).', 'armGroupLabels': ['Conventional CST Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'contacts': [{'name': 'Winsy Wong, PhD', 'role': 'CONTACT', 'email': 'winsyws.wong@polyu.edu.hk', 'phone': '852 34003117'}], 'facility': 'The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Winsy WS Wong, PHD', 'role': 'CONTACT', 'email': 'wszewong@polyu.edu.hk', 'phone': '852-34003117'}], 'overallOfficials': [{'name': 'Winsy WS Wong, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Data will be shared starting from three months after manuscript publication.', 'ipdSharing': 'YES', 'description': 'The IPD, together with the study protocol, will be shared in an open-access data repository (e.g., OSF).', 'accessCriteria': 'The IPD and study protocol will be shared in an open-access data repository without restrictions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The University of Hong Kong', 'class': 'OTHER'}, {'name': 'University of Reading', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}