Effectiveness of TeleVR App in Cognitive Decline and MCI Patients

Last updated: January 24, 2025
Sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mild Cognitive Impairment

Dementia

Alzheimer's Disease

Treatment

Traditional Cognitive Rehabilitation

Telerehabilitation with Virtual Reality

Clinical Study ID

NCT06793735
TeleVR App_24
Current Research Funds 2024
  • Ages 40-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects diagnosed with MCI (AD and PD) according to the criteria of the NationalInstitute on Aging-Alzheimer's Association (NIA-AA, Albert et al., 2011)

  • Subjects diagnosed with SCD according to diagnostic criteria proposed in researchsettings (Molinuevo et al., 2017)

  • All enrolled subjects must be aged between 40 and 80 years and have at least 5 yearsof education

Exclusion

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-generationmetal joint prostheses, electrodes, neurostimulators, or prostheses that mayinterfere with magnetic fields, unless there is a written statement of suitabilityfrom the specialist who performed the intervention

Study Design

Total Participants: 480
Treatment Group(s): 2
Primary Treatment: Traditional Cognitive Rehabilitation
Phase:
Study Start date:
January 08, 2025
Estimated Completion Date:
January 31, 2026

Study 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

Connect with a study center

  • IRCCS Centro Neurolesi Bonino Pulejo

    Messina, 98124
    Italy

    Active - Recruiting

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