Therapeutic Use of rTMS in Pediatric ASD and ADHD Cohorts
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorOspedali Riuniti di Foggia
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- repetitive Transcranial Magnetic Stimulation
Treatment groups
80 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov