Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-01-01 @ 6:43 AM
Study NCT ID:
NCT06793735
Status:
RECRUITING
Last Update Posted:
2025-01-27
First Post:
2025-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of TeleVR App in Cognitive Decline and MCI Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069350', 'term': 'Telerehabilitation'}], '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'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': "This study will use a single-blind design, where outcome assessors will be blinded to group assignments to minimize bias during the evaluation of results.\n\nParticipants: Not masked. Participants will be aware of their assigned intervention (Telerehabilitation with Virtual Reality or traditional paper-based rehabilitation).\n\nHealthcare Providers/Therapists: Not masked. Therapists guiding the telerehabilitation sessions or traditional rehabilitation tasks will be aware of the group assignments.\n\nOutcome Assessors: Masked. Neuropsychological assessments, EEG analysis, gait analysis, eye movement evaluations, and MRI data interpretation will be performed by independent assessors who will not have information about group allocation.\n\nThis masking strategy ensures an objective and unbiased assessment of the study's primary and secondary outcomes."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In this randomized controlled trial (RCT), participants are assigned to one of two intervention groups:\n\nExperimental Group (EG): Participants will undergo a telerehabilitation program using two non-immersive Virtual Reality (VR) apps (NeuroNation and The Sims Mobile) on smartphones or tablets. The intervention aims to enhance cognitive and social cognition skills through interactive exercises conducted remotely.\n\nActive Control Group (aCG): Participants will follow a traditional cognitive rehabilitation program using paper-based exercises targeting similar cognitive and social domains.\n\nKey Model Details:\n\nRandomization: Participants are randomly assigned to either the experimental or control group using a block randomization method to ensure balance between groups.\n\nBlinding: Outcome assessors will be blinded to group assignments to reduce bias.\n\nDuration: Both groups will follow a 6-week intervention program, with assessments at baseline (T0), post-intervention (T1), and at a 3-month f'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-01-24', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Performance Improvement', 'timeFrame': 'The time frame for assessing cognitive performance improvement is at baseline (T0), immediately post-intervention (T1, after 6 weeks), and at follow-up (T2, 3 months after the intervention).', 'description': 'The primary objective is to evaluate the effectiveness of the telerehabilitation program combined with Virtual Reality (VR) in improving global cognitive performance. This includes assessing domains such as memory, attention, and executive functioning in patients with Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI).'}, {'measure': 'Social Cognition Enhancement', 'timeFrame': 'Social cognition improvements will be evaluated over the same time frame as cognitive performance: baseline (T0), post-intervention (T1, after 6 weeks), and follow-up (T2, 3 months after the intervention).', 'description': 'Another key objective is to examine the impact of the telerehabilitation program on social cognition skills. This involves measuring improvements in empathy, Theory of Mind, and overall social interaction abilities, which are critical for maintaining functional independence and quality of life.'}], 'secondaryOutcomes': [{'measure': 'Neurophysiological Changes', 'timeFrame': 'Neurophysiological changes will be assessed at baseline (T0) and immediately post-intervention (T1, after 6 weeks).', 'description': 'A secondary objective is to investigate the neurophysiological changes associated with the intervention. This includes analyzing EEG parameters (such as changes in alpha, theta, and beta rhythms) and MRI biomarkers (like hippocampal connectivity) to understand the underlying mechanisms driving cognitive and social improvements.'}, {'measure': 'Gait and Motor Function Improvement', 'timeFrame': 'Gait and motor function assessments will occur at baseline (T0) and post-intervention (T1, after 6 weeks).', 'description': 'This objective focuses on evaluating changes in motor function and gait performance, assessed through the Timed Up and Go (TUG) test. The aim is to explore potential links between cognitive rehabilitation and cognitive-motor integration.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telerehabilitation', 'Virtual Reality (VR)', 'Mild Cognitive Impairment (MCI)', 'Subjective Cognitive Decline (SCD)', 'Cognitive Rehabilitation'], 'conditions': ['Cognitive Dysfunction', 'Subjective Health', 'Mild Cognitive Impairment', 'Alzheimer Disease', 'Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '32903506', 'type': 'BACKGROUND', 'citation': "Isernia S, Di Tella S, Pagliari C, Jonsdottir J, Castiglioni C, Gindri P, Salza M, Gramigna C, Palumbo G, Molteni F, Baglio F. Effects of an Innovative Telerehabilitation Intervention for People With Parkinson's Disease on Quality of Life, Motor, and Non-motor Abilities. Front Neurol. 2020 Aug 13;11:846. doi: 10.3389/fneur.2020.00846. eCollection 2020."}, {'pmid': '19812460', 'type': 'BACKGROUND', 'citation': 'Barnes DE, Yaffe K, Belfor N, Jagust WJ, DeCarli C, Reed BR, Kramer JH. Computer-based cognitive training for mild cognitive impairment: results from a pilot randomized, controlled trial. Alzheimer Dis Assoc Disord. 2009 Jul-Sep;23(3):205-10. doi: 10.1097/WAD.0b013e31819c6137.'}, {'pmid': '30239213', 'type': 'BACKGROUND', 'citation': 'Amjad I, Toor H, Niazi IK, Pervaiz S, Jochumsen M, Shafique M, Haavik H, Ahmed T. Xbox 360 Kinect Cognitive Games Improve Slowness, Complexity of EEG, and Cognitive Functions in Subjects with Mild Cognitive Impairment: A Randomized Control Trial. Games Health J. 2019 Apr;8(2):144-152. doi: 10.1089/g4h.2018.0029. Epub 2018 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the effectiveness of a telerehabilitation program combined with a virtual reality (VR) app in improving cognitive performance and social skills in patients with Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI).\n\nThe main questions it aims to answer are:\n\nCan a VR telerehabilitation program improve cognitive functions and social skills in patients with SCD and MCI? Are there measurable changes in brain activity, eye movements, and gait patterns after the intervention? Researchers will compare telerehabilitation with a VR group (Experimental Group - EG) to a traditional paper-based cognitive rehabilitation group (Active Control Group - aCG) to determine which approach is more effective.\n\nParticipants will:\n\nUndergo an initial assessment, including neurological exams, neuropsychological tests, brain MRI, EEG, eye movement analysis, and gait evaluation.\n\nParticipate in a 6-week intervention program:\n\nEG: Use VR apps on smartphones/tablets at home, guided remotely by a therapist. aCG: Perform traditional cognitive exercises using paper-based tasks. Complete follow-up assessments immediately after the intervention and again after three months.\n\nThis study will help determine whether telerehabilitation with VR can provide measurable cognitive and social benefits, contributing to improved care strategies for individuals at risk of dementia.', 'detailedDescription': 'This clinical trial aims to assess the effectiveness of a telerehabilitation program combined with a virtual reality (VR) app in enhancing cognitive performance and social skills in individuals with Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI).\n\nStudy Rationale SCD and MCI are considered critical stages in identifying individuals at risk for dementia. Both conditions are associated with cognitive and social impairments, as well as neurophysiological changes observable through advanced neuroimaging and EEG markers. While traditional cognitive rehabilitation has shown benefits, emerging evidence suggests that telerehabilitation combined with VR may offer enhanced outcomes through its interactive, engaging, and scalable nature.\n\nPrimary Objective Evaluate the potential efficacy of a telerehabilitation plus VR intervention in improving cognitive performance and social cognition skills in patients with SCD and MCI.\n\nSecondary Objectives Assess neurophysiological changes (EEG and MRI biomarkers) following the intervention.\n\nEvaluate gait patterns and eye movement parameters. Investigate the usability and patient compliance of the VR app-based intervention.\n\nStudy Design Type: Randomized Clinical Trial (RCT) Duration: 6 weeks intervention, with follow-up assessments at baseline (T0), post-intervention (T1), and 3 months after intervention (T2).\n\nPopulation: Individuals aged 40-80 with SCD or MCI (AD and PD subtypes).\n\nIntervention Groups:\n\nExperimental Group (EG): Participants will use two non-immersive VR apps ("NeuroNation" and "The Sims Mobile") on smartphones/tablets for cognitive and socio-emotional skill training. Training will occur 3 times per week, 30 minutes per session, guided remotely by therapists.\n\nActive Control Group (aCG): Participants will follow a traditional cognitive rehabilitation program using paper-based exercises targeting cognitive domains.\n\nAssessment Tools:\n\nNeuropsychological Assessment: MMSE, MoCA, FAB, Stroop Test, RAVLT, Trail Making Test (TMT-A/B), and more.\n\nNeurophysiological Assessment: EEG and MRI scans for brain activity and structural analysis.\n\nGait Analysis: Timed Up and Go (TUG) Test with BTS G-WALK®. Eye Movement Analysis: Using an eye-tracking system for fixation, saccades, antisaccades, and smooth pursuit eye movements.\n\nUsability Assessment: System Usability Scale (SUS).\n\nExpected Outcomes:\n\nImproved cognitive and social cognition performance in the experimental group compared to the control group.\n\nObservable changes in EEG and MRI biomarkers correlating with cognitive improvements.\n\nEnhanced usability and acceptance of VR-based telerehabilitation tools among participants.\n\nSignificance of the Study:\n\nThis trial seeks to bridge the gap between traditional cognitive rehabilitation and innovative, scalable, and cost-effective digital health interventions. Positive outcomes could establish telerehabilitation with VR as a standard intervention for cognitive and social rehabilitation in at-risk populations.\n\nThe study adheres to ethical principles outlined in the Declaration of Helsinki, and informed consent will be obtained from all participants before enrollment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects diagnosed with MCI (AD and PD) according to the criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA, Albert et al., 2011)\n* Subjects diagnosed with SCD according to diagnostic criteria proposed in research settings (Molinuevo et al., 2017)\n* All enrolled subjects must be aged between 40 and 80 years and have at least 5 years of education\n\nExclusion Criteria:\n\n* Presence of psychiatric disorders (major depression, psychosis, anxiety disorders)\n* Presence of severe dementia\n* History of cerebral ischemia\n* Contraindications to brain MRI: pregnant women, pacemakers, non-latest-generation metal joint prostheses, electrodes, neurostimulators, or prostheses that may interfere with magnetic fields, unless there is a written statement of suitability from the specialist who performed the intervention"}, 'identificationModule': {'nctId': 'NCT06793735', 'acronym': 'TeleVR24', 'briefTitle': 'Effectiveness of TeleVR App in Cognitive Decline and MCI Patients', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Centro Neurolesi Bonino Pulejo'}, 'officialTitle': 'Effectiveness of Telerehabilitation Plus Virtual Reality App in Patients With Subjective Cognitive Decline, and Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': 'TeleVR App_24'}, 'secondaryIdInfos': [{'id': 'Current Research Funds 2024', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Health, Italy'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tele-VR Group', 'description': 'Participants in this arm will undergo a Telerehabilitation program using Virtual Reality (VR) apps. This intervention is designed to improve cognitive and social cognition skills through interactive, engaging exercises conducted remotely.', 'interventionNames': ['Device: Telerehabilitation with Virtual Reality']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Control Group (aCG)', 'description': 'Participants in this arm will receive a traditional cognitive rehabilitation program using paper-based exercises. The intervention targets the same cognitive and social domains as the experimental group but uses conventional rehabilitation methods.', 'interventionNames': ['Other: Traditional Cognitive Rehabilitation']}], 'interventions': [{'name': 'Telerehabilitation with Virtual Reality', 'type': 'DEVICE', 'description': 'Participants assigned to the experimental group will engage in a six-week telerehabilitation program utilizing two non-immersive Virtual Reality (VR) applications, NeuroNation and The Sims Mobile. These apps are designed to enhance cognitive performance and social cognition skills through interactive and scientifically validated exercises. NeuroNation focuses on improving memory, attention, reasoning speed, and mental flexibility, while The Sims Mobile engages participants in realistic social scenarios that challenge their empathy, communication, and problem-solving abilities. The intervention involves three 30-minute sessions per week, which participants will complete remotely using smartphones or tablets. Therapists will provide weekly virtual check-ins to monitor progress, address questions, and ensure adherence to the protocol. This program aims to create an engaging and accessible rehabilitation experience while promoting real-life application of cognitive and social skills improv', 'armGroupLabels': ['Tele-VR Group']}, {'name': 'Traditional Cognitive Rehabilitation', 'type': 'OTHER', 'description': 'Participants in the control group will follow a traditional rehabilitation protocol that relies on paper-based cognitive exercises. This program targets cognitive domains such as attention, memory, and executive functions through tasks like puzzles, memory challenges, and problem-solving activities. The intervention also spans six weeks, with participants completing three 30-minute sessions per week. During an initial session, participants will receive all necessary materials and instructions for completing the exercises independently at home. Therapists will provide weekly remote support via phone or video to track progress and address any concerns. This conventional approach serves as a baseline for comparison with the innovative telerehabilitation method in the experimental group.', 'armGroupLabels': ['Active Control Group (aCG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98124', 'city': 'Messina', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Grazia Maggio, PhD, PsyD', 'role': 'CONTACT', 'email': 'mariagrazia.maggio@irccsme.it', 'phone': '+39 09062128250'}, {'name': 'Rocco Salvatore Calabrò, PhD, MD', 'role': 'CONTACT', 'email': 'roccos.calabro@irccsme.it', 'phone': '+3909062128152'}, {'name': 'Maria Grazia Maggio, PhD, PsyD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Centro Neurolesi Bonino Pulejo', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}], 'centralContacts': [{'name': 'Maria Grazia Maggio, PhD, PsyD', 'role': 'CONTACT', 'email': 'mariagrazia.maggio@irccsme.it', 'phone': '+39 090 62128250'}], 'overallOfficials': [{'name': 'Rosso Salvatore Calabrò, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS Centro Neurolesi Bonino Pulejo'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': "IPD and supporting documentation, including the Statistical Analysis Plan (SAP), will be available starting 6 months after the study's primary completion date. Access will be provided for 5 years from the initial availability date, ensuring adequate time for secondary analyses while maintaining relevance to ongoing research efforts.", 'ipdSharing': 'YES', 'description': "IPD related to primary and secondary outcome measures will be shared. This includes data on cognitive performance, social cognition, neurophysiological parameters (EEG and MRI biomarkers), gait analysis, and eye movement metrics. Data will be made available to qualified researchers upon reasonable request, following ethical and legal guidelines to ensure participant confidentiality. Access will be provided through a secure platform for a limited period after the study's completion. Specific requests will be evaluated on a case-by-case basis, and approved researchers must agree to terms of use.", 'accessCriteria': "Requests for access to Individual Participant Data (IPD) and supporting documentation will be evaluated by the study's data-sharing committee. Researchers must submit a proposal detailing their study objectives, statistical analysis plans, and ethical approval. Access will be granted for scientifically valid purposes, following a signed data use agreement. Requests should be directed to: mariagrazia.maggio@irccsme.it."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Centro Neurolesi Bonino Pulejo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Health Researcher', 'investigatorFullName': 'Maria Grazia Maggio', 'investigatorAffiliation': 'IRCCS Centro Neurolesi Bonino Pulejo'}}}}