Effectiveness of TeleVR App in Cognitive Decline and MCI Patients
Recruiting · NCT06793735 · Interventional (participants receive a specific treatment) · Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- IRCCS Centro Neurolesi Bonino Pulejo - Messina, Italy, Italy