Effectiveness of TeleVR App in Cognitive Decline and MCI Patients

NCT06793735 | Recruiting DMC

• 2 other identifiers: TeleVR App_24Current Research Funds 2024
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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 (2)

• Neurophysiological Changes

  Neurophysiological changes will be assessed at baseline (T0) and immediately post-intervention (T1, after 6 weeks).

• Gait and Motor Function Improvement

  Gait and motor function assessments will occur at baseline (T0) and post-intervention (T1, after 6 weeks).

Study Arms (2)

Tele-VR Group

EXPERIMENTAL

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

Active Control Group (aCG)

ACTIVE COMPARATOR

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

Interventions

Telerehabilitation with Virtual Reality DEVICE

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

Tele-VR Group

Traditional Cognitive Rehabilitation OTHER

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.

Active Control Group (aCG)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Centro Neurolesi Bonino Pulejo

Messina, 98124, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 32903506 BACKGROUND

• 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.

  PMID: 19812460 BACKGROUND

• Amjad I, Toor H, Niazi IK, Pervaiz S, Jochumsen M, Shafique M, Haavik H, Ahmed T. Xbox 360 Kinect Cognitive Games Improve Slowness, Complexity of EEG, and Cognitive Functions in Subjects with Mild Cognitive Impairment: A Randomized Control Trial. Games Health J. 2019 Apr;8(2):144-152. doi: 10.1089/g4h.2018.0029. Epub 2018 Sep 21.

  PMID: 30239213 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Parkinson Disease

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Rosso Salvatore Calabrò, MD,PhD

  IRCCS Centro Neurolesi Bonino Pulejo

  STUDY DIRECTOR

Central Study Contacts

Maria Grazia Maggio, PhD, PsyD

CONTACT

+39 090 62128250; mariagrazia.maggio@irccsme.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This study will use a single-blind design, where outcome assessors will be blinded to group assignments to minimize bias during the evaluation of results. Participants: Not masked. Participants will be aware of their assigned intervention (Telerehabilitation with Virtual Reality or traditional paper-based rehabilitation). Healthcare Providers/Therapists: Not masked. Therapists guiding the telerehabilitation sessions or traditional rehabilitation tasks will be aware of the group assignments. Outcome Assessors: Masked. Neuropsychological assessments, EEG analysis, gait analysis, eye movement evaluations, and MRI data interpretation will be performed by independent assessors who will not have information about group allocation. This masking strategy ensures an objective and unbiased assessment of the study's primary and secondary outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Researcher

Model Details: 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

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 27, 2025
• Study Start: January 8, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• 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.

Locations

IT (1)