Virtual reality to boost neuroplasticity in children and adolescents
M.I.N.E.R.V.A., Metodologie Innovative Per la Neuroplasticità in Età Evolutiva Con l'Uso Della Realtà Virtuale a Scopo Abilitativo
This project will try immersive virtual reality rehabilitation to improve attention, motor skills, social interaction, and quality of life in children and teens aged 8–18 with ADHD, autism, or cerebral palsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | IRCCS Centro Neurolesi Bonino Pulejo Academic / other |
| Locations | 1 site (Messina, Messina) |
| Trial ID | NCT07426315 on ClinicalTrials.gov |
What this trial studies
The study enrolls children and adolescents aged 8–18 with diagnoses of ADHD, ASD, or cerebral palsy and delivers immersive virtual reality (IVR) rehabilitation using the CAREN platform alongside conventional interventions. Participants complete a course of IVR sessions designed to target cognitive, motor, and social skills with baseline and follow-up assessments of attention, motor function, social interaction, and quality of life. Outcomes from the IVR program will be compared with standard rehabilitation approaches to see if IVR yields greater engagement and broader functional gains. Safety, tolerability, and the feasibility of integrating IVR into pediatric rehabilitation are also recorded.
Who should consider this trial
Good fit: Children and adolescents aged 8–18 with a clinical diagnosis of ADHD, ASD, or cerebral palsy who can follow instructions and have sufficient cognitive and motor abilities to use the IVR system are ideal candidates.
Not a fit: Children with severe cognitive or intellectual disability, uncontrolled epilepsy, major psychiatric disorders, or severe motor impairments that prevent use of the IVR platform are unlikely to benefit.
Why it matters
Potential benefit: If successful, IVR rehabilitation could make therapy more engaging and produce measurable gains in attention, movement, social interaction, and overall quality of life for affected children.
How similar studies have performed: Smaller and observational studies have reported promising engagement and functional gains with virtual reality in pediatric neurorehabilitation, but large randomized trials are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children and adolescents aged 8 to 18 years * Diagnosis of one of the following neurodevelopmental disorders: * Attention Deficit Hyperactivity Disorder (ADHD) * Autism Spectrum Disorder (ASD) * Cerebral Palsy (CP) * Ability to understand and comply with instructions for the intervention * Adequate cognitive, motor, and social skills to participate in the rehabilitation program * Informed consent obtained from a parent or legal guardian Exclusion Criteria: * Children and adolescents younger than 8 or older than 18 years * Severe cognitive impairments or intellectual disabilities that prevent participation in the rehabilitation program * Diagnosis of conditions not related to the target neurodevelopmental disorders, such as: * Major psychiatric disorders (e.g., severe depression, schizophrenia) * Neurological disorders not included in the study (e.g., epilepsy) * Severe motor impairments that prevent interaction with the virtual reality platform * Uncontrolled medical conditions (e.g., severe cardiovascular, respiratory, or endocrine diseases) * Lack of informed consent from a parent or legal guardian * Participation in another intervention or study that may interfere with the rehabilitation program * Behavioral issues or extreme anxiety that make it impossible to follow instructions or interact with the virtual reality system
Where this trial is running
Messina, Messina
- IRCCS Neurolesi Bonino Pulejo — Messina, Messina, Italy (Recruiting)
Study contacts
- Study coordinator: Francesca Cucinotta
- Email: francesca.cucinotta@irccsme.it
- Phone: 09060128256
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.