NCT06069323 Therapeutic Use of rTMS in Pediatric ASD and ADHD Cohorts
| NCT ID | NCT06069323 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ospedali Riuniti di Foggia |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2023-06-01 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Anna N Polito, MD
STUDY CHAIR
Neuropsychiatric Unit for Child and Adolescent, at General Hospital "Riuniti" of Foggia
Frequently Asked Questions
Who can join the NCT06069323 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06069323 currently recruiting?
Yes, NCT06069323 is actively recruiting participants. Contact the research team at rosa.savino@unifg.it for enrollment information.
Where is the NCT06069323 trial being conducted?
This trial is being conducted at Foggia, Italy.
Who is sponsoring the NCT06069323 clinical trial?
NCT06069323 is sponsored by Ospedali Riuniti di Foggia. The principal investigator is Anna N Polito, MD at Neuropsychiatric Unit for Child and Adolescent, at General Hospital "Riuniti" of Foggia. The trial plans to enroll 80 participants.