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NCT07828457Not yet recruiting

Interventional rTMS for Improving Social Perception in Autism

Source: ClinicalTrials.gov · Last updated 18 Sept 2026

Brief summary (registry, in English)

Autism spectrum disorder (ASD) is a neurodevelopmental condition mainly characterized by difficulties in social interaction and social communication. Over the last 30 years, neuroimaging studies have identified anatomical and functional abnormalities localized in the superior temporal sulcus (STS) in individuals with ASD. The STS is a brain region that plays a central role in the perception and interpretation of social information. These findings make the STS a particularly relevant target for developing new therapeutic approaches aimed at improving social difficulties associated with ASD. The IRIS study aims to evaluate the effects of a non-invasive neuromodulation technique, transcranial magnetic stimulation (TMS), on social perception and social behavior in pre-adolescents and adolescents with ASD aged 10 to 17 years. The stimulation protocol, called intermittent theta-burst stimulation (iTBS), will target the right posterior STS. Previous studies conducted by the research team have established the feasibility and good tolerability of this approach in young adults with ASD. This is a randomized, double-blind, placebo-controlled clinical trial involving 16 participants and using a crossover design. Each participant will receive both active and placebo stimulation, in a randomized order, with an interval of approximately three months between the two periods. Each treatment period will consist of five sessions per day for four consecutive days, for a total of 20 sessions. The effects of the intervention on social perception and behavior will be objectively assessed using eye-tracking during the viewing of social scenes. Brain MRI will also be used to investigate potential changes in brain function, connectivity, and structure. In addition, clinical scales completed with the parents will be used to assess social behavior and overall functioning. The study will therefore determine whether an accelerated TMS protocol targeting a brain region involved in social cognition can improve social perception and behavior in young people with ASD, while also assessing its safety, tolerability, and effects on brain function.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
16 (estimated)
First submitted
11 Sept 2026
Start date
Oct 2026
Primary completion date
Nov 2028
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Diseases
Autism
NCT number
NCT07828457

What you commit to

  • Study type: Interventional
  • Planned participants: 16
  • From Oct 2026 to the primary completion date, Nov 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Initiation, discontinuation, or modification of treatment with neuroleptics or benzodiazepines during the previous month (unstable treatment)

Other illness

  • Presence of epilepsy or a history of seizures.
  • Contraindication to TMS, including personal or family history of epilepsy, history of craniotomy, cardiac pacemaker, intraocular or intracerebral metallic foreign body, cochlear implant, cardiac valve or metallic surgical material, or any material likely to concentrate radiofrequency pulses, and open wounds on the head or irritated scalp.
  • Contraindication to MRI, including cardiac pacemaker, intracorporeal metallic foreign body, or occupational exposure to metallic particles.
  • Presence of a neurological condition (epilepsy, cerebral palsy, neuromuscular disease, neurological sequelae of brain injury, or central nervous system malformation)

Other

  • Pregnancy or breastfeeding (based on patient/parental interview).
  • Current participation in another clinical trial.

Who the study is looking for

  • Diagnosis of Autism Spectrum Disorder (ASD) according to DSM-5 criteria and confirmed by the Autism Diagnostic Interview-Revised (ADI-R).
  • Aged 10 to 17 years, inclusive.
  • Able to undergo an MRI examination.
  • Affiliated with or beneficiary of a social
  • Affiliated with or beneficiary of a social security system.
  • Written informed consent provided by the participant and/or their legal representative

Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hôpital Necker - Enfants Malades - Service de radiologie pédiatrique
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Plateforme CENIR_PANAM au centre de Neuro Imagerie de recherche à l' " Institut du Cerveau " (ICM)
Coordinator of this site? Confirm its status
ParisFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.