Repetitive transcranial magnetic stimulation in children and adolescents with autism spectrum disorder: study protocol for a double-blind, sham-controlled, randomized clinical trial.

Researchers are planning a study to test whether a brain stimulation technique called rTMS might help children and teens with autism (ages 7-18). The treatment uses magnetic pulses to stimulate specific brain areas. Forty children will participate - half receiving real treatment, half receiving fake treatment (neither child nor researcher will know which). The study will measure whether rTMS helps with autism symptoms and is safe for young people.

This study protocol outlines a double-blind, sham-controlled randomized clinical trial investigating repetitive transcranial magnetic stimulation (rTMS) for children and adolescents with autism spectrum disorder. Forty participants aged 7-18 years will be randomized to receive either active low-frequency rTMS or sham stimulation targeting the bilateral dorsolateral prefrontal cortex over 9 weeks (18 sessions). The intervention addresses neurobiological characteristics of ASD including cortical excitation/inhibition imbalances and neural connectivity disruptions. Comprehensive assessments include clinical, cognitive, and neurophysiological measures, plus biomarker analysis of blood and urine samples.

The protocol aims to evaluate rTMS efficacy compared to sham stimulation and identify optimal treatment parameters for pediatric ASD populations.

This protocol represents a systematic approach to evaluating rTMS as a potential adjunct therapy for pediatric ASD. The comprehensive assessment including biomarkers may help identify which children respond best to treatment. Results could inform future clinical practice guidelines for brain stimulation therapies in autism.

This is a protocol paper with no results reported. The study is ongoing and outcomes are not yet available. Sample size of 40 participants may limit generalizability of future findings.

The prevalence of autism spectrum disorder (ASD) has significantly increased over recent decades, representing a serious public health issue. Neurobiological characteristics of ASD include imbalances in cortical excitation and inhibition, along with disruptions in neural network connectivity. Repetitive transcranial magnetic stimulation (rTMS) may provide a therapeutic option when cognitive-behavioral therapy alone is insufficient to alleviate core symptoms. This article outlines the protocol for a double-blind, sham-controlled, randomized study assessing low-frequency rTMS targeting the bilateral dorsolateral prefrontal cortex (DLPFC) in children and adolescents with ASD.

The objective is to evaluate the efficacy of rTMS compared to sham stimulation. Forty patients with ASD, aged 7-18 years and with different levels of clinical severity, will be randomized into an active treatment group (n = 20) and a sham control group (n = 20). Each participant will receive 18 low-frequency (2 Hz) rTMS sessions over 9 weeks, administered at 90% of the motor threshold with 180 pulses per session. Treatment will target the left DLPFC (six sessions), the right DLPFC (six sessions), and both hemispheres (six sessions).

Clinical, cognitive, and neurophysiological assessments will be conducted at baseline, post-treatment, and 1-month follow-up. Biological samples (blood, urine) will be collected at each time point to evaluate changes in various biomarkers, including tryptophan metabolites, neurotrophic factors, neurotransmitters, and inflammatory mediators. Safety will be monitored through semi-structured interviews and adverse event reporting. This study aims to identify a safe rTMS protocol for ASD that could complement existing therapies.

By assessing the cognitive domains and the clinical and biochemical profiles most responsive to rTMS, this study may contribute to optimize ASD treatments and enhance therapeutic outcomes in pediatric populations. The study protocol is registered at "ClinicalTrials.gov" with the following ID: NCT06069323.