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.
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)
Subjects diagnosed with SCD according to diagnostic criteria proposed in research settings (Molinuevo et al., 2017)
All enrolled subjects must be aged between 40 and 80 years and have at least 5 years of education
Presence of psychiatric disorders (major depression, psychosis, anxiety disorders)
Presence of severe dementia
History of cerebral ischemia
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
Parallel
Telerehabilitation with Virtual Reality
DeviceParticipants 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
Traditional Cognitive Rehabilitation
Other interventionParticipants 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).
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.
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.
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.
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