Evidence map›Paper›PMID 40619411›Full record

ArticleTrials2025

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

Rosa Savino, Sergio Davinelli, Anna Nunzia Polito, Giovanni Scapagnini, Aldo Scirano, Anna Valenzano, Giuseppe Cibelli

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06069323 (Therapeutic Use of Repetitive Transcranial Magnetic Stimulation), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06069323 naunknown statusnot on this map

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.

TypeinterventionalSponsorOspedali Riuniti di FoggiaRan2023 to 2026Enrolled80ConditionsAutism Spectrum Disorder, ADHD, Neurodevelopmental DisordersArmsrepetitive Transcranial Magnetic Stimulation
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Rosa SavinoDepartment of Woman and Child, Neuropsychiatry for Child and Adolescent Unit, General Hospital "Riuniti", Foggia, Italy. rosa.savino@unifg.it.ORCID http://orcid.org/0000-0001-6439-0317
Sergio DavinelliDepartment of Medicine and Health Sciences "V. Tiberio", University of Molise, Campobasso, Italy.
Anna Nunzia PolitoDepartment of Woman and Child, Neuropsychiatry for Child and Adolescent Unit, General Hospital "Riuniti", Foggia, Italy.
Giovanni ScapagniniDepartment of Medicine and Health Sciences "V. Tiberio", University of Molise, Campobasso, Italy.
Aldo SciranoDepartment of Woman and Child, Neuropsychiatry for Child and Adolescent Unit, General Hospital "Riuniti", Foggia, Italy.
Anna ValenzanoDepartment of Clinical and Experimental Medicine, University of Foggia, Foggia, Italy.
Giuseppe CibelliDepartment of Clinical and Experimental Medicine, University of Foggia, Foggia, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsForty 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. DISCUSSION: 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.

trial registrationThe study protocol is registered at "ClinicalTrials.gov" with the following ID: NCT06069323.

Indexed as

Adolescent BehaviorAutism Spectrum DisorderDorsolateral Prefrontal CortexTranscranial Magnetic StimulationAdolescentAge FactorsChildChild BehaviorCognitionDouble-Blind MethodFemaleHumansMaleRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeAutism spectrum disorderBiomarkersDorsolateral prefrontal cortexNeurostimulationRandomized controlled trialRepetitive transcranial magnetic stimulation

Identifiers

PMID40619411
PMCPMC12232753

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.