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.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Italy
Neuropsychiatric Unit for Child and Adolescent, at General Hospital Riuniti of Foggia, University of Foggia
RECRUITING
Foggia
Contact Information
Primary
Rosa Savino, MD
rosa.savino@unifg.it
+ 39 0881732363
Backup
Giuseppe Cibelli, Prof
giuseppe.cibelli@unifg.it
+ 39 0881588034
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 80
Treatments
Active_comparator: Active ASD group
The rTMS will be administered 18 times, twice per week, with the following stimulation parameters: 1.0 Hz frequency, 90% MT, 180 pulses per session with 9 trains of 20 pulses each with 20-30s intervals between the trains.
Sham_comparator: Sham ASD group
18 rTMS sessions will be administered, placing the coil perpendicular to the scalp of the stimulation site, to avoid stimulation.
Active_comparator: Active ADHD group
The rTMS will be administered 18 times, twice per week, with the following parameters: 5-10 Hz frequency, 90% MT, 180 pulses per session with 9 trains of 20 pulses each with 20-30 s intervals between the trains.
Sham_comparator: Sham ADHD group
18 rTMS sessions will be administered, placing the coil perpendicular to the scalp of the stimulation site, to avoid stimulation.
Sponsors
Leads: Ospedali Riuniti di Foggia

This content was sourced from clinicaltrials.gov