NCT07426302

Virtual Reality-assisted Cognitive Rehabilitation in Autistic Youth With ADHD

A Randomized Controlled Trial on the Effectiveness of Virtual Reality-assisted Executive Function Training in Autistic and ADHD Youth

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: IRCCS Centro Neurolesi Bonino Pulejo · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effectiveness of a virtual reality-based intervention using the Virtual Reality Rehabilitation System (VRRS) to improve executive functions in autistic and ADHD youth aged 8 to 18 years. Executive functions, such as working memory, cognitive flexibility, and inhibitory control, are frequently impaired in individuals with autism and/or ADHD and significantly affect daily functioning. Participants will be randomly assigned to either an experimental group that receives VRRS-assisted cognitive training or a control group that receives treatment as usual. The intervention includes gamified tasks within immersive virtual environments specifically designed to stimulate executive skills. The primary outcome is the change in executive function scores from baseline to post-intervention, assessed using validated neuropsychological instruments. The study adopts a randomized controlled design.

Conditions

• ADHD - Attention Deficit Disorder With Hyperactivity
• Autism Spectrum Disorder

Interventions

Type	Name	Description
BEHAVIORAL	VRRS Cognitive Training	VRRS is a virtual reality system designed to offer interactive cognitive exercises in an immersive environment. Participants will complete 20 sessions (one session per week). Each session lasts approx
BEHAVIORAL	Treatment as Usual (TAU)	Participants will receive the usual care typically provided in clinical or educational settings, such as attention training, memory exercises, or academic support. The frequency and duration of sessions will be comparable to the experimental group, but without the use of VR technology.

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-06-30
• Completion: 2026-07-01
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: Italy