Clinical trial NCT06793735: Effectiveness of TeleVR App in Cognitive Decline and MCI Patients
Official title: Effectiveness of Telerehabilitation Plus Virtual Reality App in Patients With Subjective Cognitive Decline, and Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Dysfunction
Subjective Health
Mild Cognitive Impairment
Alzheimer Disease
Parkinson Disease
Keywords: Telerehabilitation
Virtual Reality (VR)
Mild Cognitive Impairment (MCI)
Subjective Cognitive Decline (SCD)
Cognitive Rehabilitation
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 480
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this randomized controlled trial (RCT), participants are assigned to one of two intervention groups:

Experimental 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.

Active Control Group (aCG): Participants will follow a traditional cognitive rehabilitation program using paper-based exercises targeting similar cognitive and social domains.

Key Model Details:

Randomization: Participants are randomly assigned to either the experimental or control group using a block randomization method to ensure balance between groups.

Blinding: Outcome assessors will be blinded to group assignments to reduce bias.

Duration: Both groups will follow a 6-week intervention program, with assessments at baseline (T0), post-intervention (T1), and at a 3-month f
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
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).
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).
Secondary outcomes:
measure: Neurophysiological Changes
timeFrame: Neurophysiological changes will be assessed at baseline (T0) and immediately post-intervention (T1, after 6 weeks).
measure: Gait and Motor Function Improvement
timeFrame: Gait and motor function assessments will occur at baseline (T0) and post-intervention (T1, after 6 weeks).
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino Pulejo
Study officials:
affiliation: IRCCS Centro Neurolesi Bonino Pulejo
name: Rosso Salvatore Calabrò, MD,PhD
role: STUDY_DIRECTOR
References:
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.
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.
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