RECRUITINGINTERVENTIONAL

Therapeutic Use of rTMS in Pediatric ASD and ADHD Cohorts

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.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients must have received a diagnosis of "ASD" or "ADHD" according to the Diagnostic and Statistical Manual of Mental Disorder-Fifth edition. - Patients must be older than 6-7 years of age, to obtain their collaboration easily Who Should NOT Join This Trial: - presence of known neurological or genetic conditions that are known to affect brain function and structure (i.e. brain tumors, X-fragile, tuberous sclerosis, etc.). - prescription of psychoactive medication(s) less than 4 weeks prior to joining the study. - medical history of head trauma associated with prolonged loss of consciousness. - presence of epilepsy, or history of previous epilepsy, seizures, and repeated febrile seizures. - presence of comorbidity with psychosis disorder. - presence of known endocrine, cardiovascular, pulmonary, liver, kidney, or other medical diseases. - vision and auditory impairment. - presence of diagnosed chronic or acute inflammation and/or infection. - lack of consent. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Patients must have received a diagnosis of "ASD" or "ADHD" according to the Diagnostic and Statistical Manual of Mental Disorder-Fifth edition. * Patients must be older than 6-7 years of age, to obtain their collaboration easily Exclusion Criteria: * presence of known neurological or genetic conditions that are known to affect brain function and structure (i.e. brain tumors, X-fragile, tuberous sclerosis, etc.). * prescription of psychoactive medication(s) less than 4 weeks prior to joining the study. * medical history of head trauma associated with prolonged loss of consciousness. * presence of epilepsy, or history of previous epilepsy, seizures, and repeated febrile seizures. * presence of comorbidity with psychosis disorder. * presence of known endocrine, cardiovascular, pulmonary, liver, kidney, or other medical diseases. * vision and auditory impairment. * presence of diagnosed chronic or acute inflammation and/or infection. * lack of consent.

Treatments Being Tested

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