An interventional study of Telerehabilitation with Virtual Reality and Traditional Cognitive Rehabilitation in Cognitive Dysfunction, Subjective Health and Mild Cognitive Impairment, sponsored by IRCCS Centro Neurolesi Bonino Pulejo. Recruiting at 1 site in Italy. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by IRCCS Centro Neurolesi Bonino Pulejo · Not applicable, Interventional, and Treatment
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).
The main questions it aims to answer are:
Can 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.
Participants will:
Undergo an initial assessment, including neurological exams, neuropsychological tests, brain MRI, EEG, eye movement analysis, and gait evaluation.
Participate in a 6-week intervention program:
EG: 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.
This 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.
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).
Study 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.
Primary 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.
Secondary Objectives Assess neurophysiological changes (EEG and MRI biomarkers) following the intervention.
Evaluate gait patterns and eye movement parameters. Investigate the usability and patient compliance of the VR app-based intervention.
Study 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).
Population: Individuals aged 40-80 with SCD or MCI (AD and PD subtypes).
Intervention Groups:
Experimental 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.
Active Control Group (aCG): Participants will follow a traditional cognitive rehabilitation program using paper-based exercises targeting cognitive domains.
Assessment Tools:
Neuropsychological Assessment: MMSE, MoCA, FAB, Stroop Test, RAVLT, Trail Making Test (TMT-A/B), and more.
Neurophysiological Assessment: EEG and MRI scans for brain activity and structural analysis.
Gait 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.
Usability Assessment: System Usability Scale (SUS).
Expected Outcomes:
Improved cognitive and social cognition performance in the experimental group compared to the control group.
Observable changes in EEG and MRI biomarkers correlating with cognitive improvements.
Enhanced usability and acceptance of VR-based telerehabilitation tools among participants.
Significance of the Study:
This 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.
The study adheres to ethical principles outlined in the Declaration of Helsinki, and informed consent will be obtained from all participants before enrollment
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 480 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →IRCCS Centro Neurolesi Bonino Pulejo is the lead sponsor of 67 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Telerehabilitation with Virtual Reality
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.
Other: Traditional Cognitive Rehabilitation
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
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.
Cognitive Performance Improvement
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).
Time frame: 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).
Social Cognition Enhancement
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.
Time frame: 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).
Neurophysiological Changes
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.
Time frame: Neurophysiological changes will be assessed at baseline (T0) and immediately post-intervention (T1, after 6 weeks).
Gait and Motor Function Improvement
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.
Time frame: Gait and motor function assessments will occur at baseline (T0) and post-intervention (T1, after 6 weeks).
Plan to share: Yes — 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.
Supporting information: Statistical analysis plan
Time frame: 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.
Access criteria: 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.
Started Jan 2025 (actual). Primary completion is estimated for Oct 2026, 21 months after the start.
Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 21 months is below that.
Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
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IRCCS Centro Neurolesi Bonino Pulejo