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Virtual Reality-assisted Cognitive Rehabilitation in Autistic Youth With ADHD

NCT07426302 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-23

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • IRCCS Centro Neurolesi Bonino Pulejo

    lead OTHER

Principal Investigators

  • Cucinotta Francesca, CF · IRCCS Neurolesi Bonino Pulejo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2026-06-30
Completion
2026-07-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07426302 on ClinicalTrials.gov