NCT06793735 Effectiveness of TeleVR App in Cognitive Decline and MCI Patients
| NCT ID | NCT06793735 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Centro Neurolesi Bonino Pulejo |
| Condition | Cognitive Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2025-01-08 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 480 participants in total. It began in 2025-01-08 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Rosso Salvatore Calabrò, MD,PhD
STUDY DIRECTOR
IRCCS Centro Neurolesi Bonino Pulejo
Frequently Asked Questions
Who can join the NCT06793735 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Cognitive Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06793735 currently recruiting?
Yes, NCT06793735 is actively recruiting participants. Contact the research team at mariagrazia.maggio@irccsme.it for enrollment information.
Where is the NCT06793735 trial being conducted?
This trial is being conducted at Messina, Italy.
Who is sponsoring the NCT06793735 clinical trial?
NCT06793735 is sponsored by IRCCS Centro Neurolesi Bonino Pulejo. The principal investigator is Rosso Salvatore Calabrò, MD,PhD at IRCCS Centro Neurolesi Bonino Pulejo. The trial plans to enroll 480 participants.