Cognitive DysfunctionTeleVR24NCT06793735
Effectiveness of TeleVR App in Cognitive Decline and MCI Patients
A study testing Telerehabilitation with Virtual Reality and Traditional Cognitive Rehabilitation in people with Cognitive Dysfunction and Subjective Health, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cognitive Dysfunction, Subjective Health, Mild Cognitive Impairment
- What is being tested?
- Telerehabilitation with Virtual Reality and Traditional Cognitive Rehabilitation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Centro Neurolesi Bonino Pulejo
Messina, Italy, 98124
Maria Grazia Maggio, PhD, PsyD, +39 09062128250, mariagrazia.maggio@irccsme.it
Rocco Salvatore Calabrò, PhD, MD, +3909062128152, roccos.calabro@irccsme.it
About this study
Official title: Effectiveness of Telerehabilitation Plus Virtual Reality App in Patients With Subjective Cognitive Decline, and Mild Cognitive Impairment
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:
Read more
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.
Read the 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
- Conditions
- Cognitive Dysfunction, Subjective Health, Mild Cognitive Impairment, Alzheimer Disease, Parkinson Disease
- Being tested
- Telerehabilitation with Virtual Reality, Traditional Cognitive Rehabilitation
- Keywords
- Telerehabilitation, Virtual Reality (VR), Mild Cognitive Impairment (MCI), Subjective Cognitive Decline (SCD), Cognitive Rehabilitation
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation with Virtual RealityDevice
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
Traditional Cognitive RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional Cognitive Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
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.
Measured: Neurophysiological changes will be assessed at baseline (T0) and immediately post-intervention (T1, after 6 weeks).
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.
Measured: Gait and motor function assessments will occur at baseline (T0) and post-intervention (T1, after 6 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start8 Jan 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Grazia Maggio, IRCCS Centro Neurolesi Bonino Pulejo
- Investigators
- Rosso Salvatore Calabrò, MD,PhD, Study director, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793735
- Sponsor's protocol ID
- TeleVR App_24
- Other IDs
- Current Research Funds 2024
- Acronym
- TeleVR24
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD related to primary and secondary outcome measures will be shared. This includes data on cognitive performance, social cognition, neurophysiological parameters (EEG and MRI biomarkers), gait analysis, and eye movement metrics. Data will be made available to qualified researchers upon reasonable request, following ethical and legal guidelines to ensure participant confidentiality. Access will be provided through a secure platform for a limited period after the study's completion. Specific requests will be evaluated on a case-by-case basis, and approved researchers must agree to terms of use.
Publications
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.
PubMed 32903506Barnes 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.
PubMed 19812460Amjad 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.
PubMed 30239213
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Telerehabilitation Plus Virtual Reality App in Patients With Subjective Cognitive Decline, and Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06793735
- Acronym / sponsor ID
- TeleVR24 / TeleVR App_24
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Tele-VR Group | Experimental | Device: Telerehabilitation with Virtual RealityParticipants 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. |
| Active Control Group (aCG) | Active comparator | Other: Traditional Cognitive RehabilitationParticipants 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation with Virtual RealityParticipants 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 | Device | Tele-VR Group |
| Traditional Cognitive RehabilitationParticipants 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. | Other | Active Control Group (aCG) |
Primary outcome
Cognitive Performance Improvement
Time frame: 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).
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
Time frame: 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).
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.
2 secondary outcomes
Neurophysiological Changes
Time frame: Neurophysiological changes will be assessed at baseline (T0) and immediately post-intervention (T1, after 6 weeks).
Gait and Motor Function Improvement
Time frame: Gait and motor function assessments will occur at baseline (T0) and post-intervention (T1, after 6 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 32903506Isernia 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.
- Background: PubMed 19812460Barnes 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.
- Background: PubMed 30239213Amjad 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.
- Individual participant dataSharing planned: Yes. IPD related to primary and secondary outcome measures will be shared. This includes data on cognitive performance, social cognition, neurophysiological parameters (EEG and MRI biomarkers), gait analysis, and eye movement metrics. Data will be made available to qualified researchers upon reasonable request, following ethical and legal guidelines to ensure participant confidentiality. Access will be provided through a secure platform for a limited period after the study's completion. Specific requests will be evaluated on a case-by-case basis, and approved researchers must agree to terms of use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rosso Salvatore Calabrò, MD,PhD study director
IRCCS Centro Neurolesi Bonino Pulejo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation with Virtual Reality and Traditional Cognitive Rehabilitation in people with Cognitive Dysfunction and Subjective Health, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Grazia Maggio, PhD, PsyD (+39 090 62128250, mariagrazia.maggio@irccsme.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Performance Improvement (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06793735, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.