Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
All Genders
NCT06793735

Effectiveness of TeleVR App in Cognitive Decline and MCI Patients

Led by IRCCS Centro Neurolesi Bonino Pulejo · Updated on 2026-04-03

480

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Effectiveness of TeleVR App in Cognitive Decline and MCI Patients

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Mild Cognitive Impairment (MCI) due to Alzheimer's Disease or Parkinson's Disease according to NIA-AA criteria
  • Diagnosed with Subjective Cognitive Decline (SCD) based on research criteria
  • Aged between 40 and 80 years
  • Have at least 5 years of education
Not Eligible

You will not qualify if you...

  • Have psychiatric disorders such as major depression, psychosis, or anxiety disorders
  • Have severe dementia
  • Have a history of cerebral ischemia
  • Have contraindications to brain MRI, such as pregnancy, pacemakers, certain metal implants, electrodes, neurostimulators, or prostheses unless cleared by a specialist

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS Centro Neurolesi Bonino Pulejo

Messina, Italy, Italy, 98124

Actively Recruiting

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Research Team

M

Maria Grazia Maggio, PhD, PsyD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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