Effectiveness of TeleVR App in Cognitive Decline and MCI Patients

Summary

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.

Conditions

• Cognitive Dysfunction
• Subjective Health
• Mild Cognitive Impairment
• Alzheimer Disease
• Parkinson Disease

Interventions

DEVICE

Telerehabilitation with Virtual Reality

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

OTHER

Traditional Cognitive Rehabilitation

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.

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo

  lead OTHER

Principal Investigators

• Rosso Salvatore Calabrò, MD,PhD · IRCCS Centro Neurolesi Bonino Pulejo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-08

Primary Completion

2026-10-31

Completion

2026-12-31

Countries

• Italy

Study Locations