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RECRUITING
NCT06069323
NA

Therapeutic Use of rTMS in Pediatric ASD and ADHD Cohorts

Sponsor: Ospedali Riuniti di Foggia

View on ClinicalTrials.gov

Summary

In this interventional, pilot clinical trial investigators will stimulate the dorsolateral prefrontal cortex (DLPFC) in patients with Autism and ADHD. The goal of the study is to improve Cognition and Executive Functions associated with this brain region and, consequently, ameliorate the core symptoms of the disorders. Specifically, the primary purpose is to establish the efficacy, safety, and tolerability of TMS in pediatric patients with ASD and ADHD. Concurrently, the research aims to uncover the impact of TMS on particular biomarkers associated with the development of these disorders and validate the hypothesis suggesting that the BDNF gene polymorphism (Val66Met) could influence an individual's susceptibility to TMS. Participants will be randomized into the active group and placebo group, to guarantee a real assessment of the impact of neurostimulation on the cognitive, behavioral, and biochemical parameters. Participants will be asked to complete a neuropsychological evaluation and a biological sample collection before and after TMS treatment, and 1-month post-treatment completion.

Official title: Therapeutic Use of Repetitive Transcranial Magnetic Stimulation (rTMS) in Pediatric Autism Spectrum Disorder (ASD) and Attention Deficit Hyperactivity Cohorts (ADHD): a Randomized, Sham-controlled Study.

Key Details

Gender

All

Age Range

6 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2023-06-01

Completion Date

2026-06

Last Updated

2023-10-05

Healthy Volunteers

Yes

Interventions

DEVICE

repetitive Transcranial Magnetic Stimulation

Pediatric patients with ASD and ADHD will be randomized both in active and sham groups.

Locations (1)

Neuropsychiatric Unit for Child and Adolescent, at General Hospital "Riuniti" of Foggia, University of Foggia

Foggia, Italy