Using brain stimulation to improve cognition in children with Autism and ADHD
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.
This study is testing whether brain stimulation can help improve thinking skills in children with Autism and ADHD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Ospedali Riuniti di Foggia Academic / other |
| Locations | 1 site (Foggia) |
| Trial ID | NCT06069323 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial aims to evaluate the efficacy, safety, and tolerability of repetitive Transcranial Magnetic Stimulation (rTMS) in pediatric patients diagnosed with Autism Spectrum Disorder (ASD) and Attention Deficit Hyperactivity Disorder (ADHD). The study will stimulate the dorsolateral prefrontal cortex (DLPFC) to enhance cognitive and executive functions, potentially alleviating core symptoms of these neurodevelopmental disorders. Participants will be randomized into active and placebo groups, and their cognitive, behavioral, and biochemical responses will be assessed through neuropsychological evaluations. Additionally, the study will explore the influence of the BDNF gene polymorphism on individual responses to TMS.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6-7 years and older who have been diagnosed with Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder.
Not a fit: Patients with known neurological or genetic conditions affecting brain function, or those with a history of epilepsy or psychosis, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive treatment option that improves cognitive functions and reduces symptoms in children with ASD and ADHD.
How similar studies have performed: While there is emerging evidence supporting the use of TMS in treating ASD and ADHD, this specific application in pediatric populations remains novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Foggia
- Neuropsychiatric Unit for Child and Adolescent, at General Hospital "Riuniti" of Foggia, University of Foggia — Foggia, Italy (Recruiting)
Study contacts
- Study coordinator: Rosa Savino, MD
- Email: rosa.savino@unifg.it
- Phone: + 39 0881732363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.