Actively Recruiting
Therapeutic Use of rTMS in Pediatric ASD and ADHD Cohorts
Led by Ospedali Riuniti di Foggia · Updated on 2023-10-05
80
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Therapeutic Use of rTMS in Pediatric ASD and ADHD Cohorts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Presence of known neurological or genetic conditions that affect brain function and structure (e.g., brain tumors, Fragile X syndrome, tuberous sclerosis).
- Prescription of psychoactive medication(s) less than 4 weeks prior to joining the study.
- Medical history of head trauma causing prolonged loss of consciousness.
- Presence or history of epilepsy, seizures, or repeated febrile seizures.
- Comorbidity with psychosis disorder.
- Known endocrine, cardiovascular, pulmonary, liver, kidney, or other medical diseases.
- Vision and auditory impairment.
- Diagnosed chronic or acute inflammation and/or infection.
- Lack of consent.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Neuropsychiatric Unit for Child and Adolescent, at General Hospital "Riuniti" of Foggia, University of Foggia
Foggia, Italy, 71122
Actively Recruiting
Research Team
R
Rosa Savino, MD
CONTACT
G
Giuseppe Cibelli, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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