Interventional rTMS for Improving Social Perception in Autism

NCT07828457 | Not Yet Recruiting

• 2 other identifiers: APHP2601082026-A00951-50
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Autism Spectrum Disorders (ASD)

Keywords

Autism Spectrum Disorder; Transcranial Magnetic Stimulation; Intermittent Theta-Burst Stimulation; Superior Temporal Sulcus; Neuromodulation; Social Cognition; Social Perception

Outcome Measures

Primary Outcomes (1)

• Change in eye-gaze pattern during social visual exploration

  Change in visual exploration of socially relevant information following active versus sham iTBS targeting the right posterior superior temporal sulcus (pSTS), assessed using eye-tracking during the presentation of social scenes. Eye-gaze patterns will be quantified using predefined areas of interest (AOIs), with fixation data extracted using Tobii eye-tracking technology and normalized for statistical analysis.

  24 hours after each 4-day iTBS treatment block (active and sham)

Secondary Outcomes (6)

• Change in resting cerebral blood flow

  24 hours after each 4-day iTBS treatment block (active and sham)

• Change in resting-state functional connectivity

  24 hours after each 4-day iTBS treatment block (active and sham)

• Change in white matter microstructure

  24 hours after each 4-day iTBS treatment block (active and sham)

• Change in social responsiveness assessed by the SRS-2

  24 hours after each 4-day iTBS treatment block (active and sham)

• Change in autism-related behaviors assessed by the ABC

  24 hours after each 4-day iTBS treatment block (active and sham)

Study Arms (2)

TMS / sham

EXPERIMENTAL

The active TMS session takes place during the first series. The second series is a sham series

Device: Neuromodulation by transcranial magnetic stimulation (TMS); Radiation: Anatomo-functional MRI; Device: Eye-tracking; Other: Social Responsiveness Scale, Second Edition (SRS-2)

Sham / TMS

EXPERIMENTAL

The active TMS session takes place during the second series. The first series is a sham series

Device: Neuromodulation by transcranial magnetic stimulation (TMS); Radiation: Anatomo-functional MRI; Device: Eye-tracking; Other: Social Responsiveness Scale, Second Edition (SRS-2)

Interventions

Neuromodulation by transcranial magnetic stimulation (TMS) DEVICE

2 series of 5 TMS applied each day, during 4 consecutive days : active or sham according randomization

Sham / TMS; TMS / sham

Anatomo-functional MRI RADIATION

For all patients, each MRI scan will include: * an ASL MRI to measure cerebral blood flow (CBF) at rest, * a resting-state functional MRI (rs-fMRI) to measure functional connectivity, * a diffusion-weighted MRI (DWI-MRI) to assess the microstructural integrity of the white matter. The total duration of each MRI scan will be approximately 30 minutes, and no injections or premedication will be used.

Sham / TMS; TMS / sham

Eye-tracking DEVICE

Eye-tracking technology records eye movements and tracks a participant's gaze while they view stimuli presented on a screen, by analyzing images of the eye captured by an infrared camera.

Sham / TMS; TMS / sham

Social Responsiveness Scale, Second Edition (SRS-2) OTHER

A Social Responsiveness Scale, Second Edition (SRS-2), Autism Behavior Checklist (ABC) and Clinical Global Impressions (CGI) will be used for assessment of Changes Induced by TMS on Social Behavior and Autistic Symptoms before the start of TMS sessions and during the 24 hours following the last stimulation session.

Sham / TMS; TMS / sham

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Initiation, discontinuation, or modification of treatment with neuroleptics or benzodiazepines during the previous month (unstable treatment)
• Pregnancy or breastfeeding (based on patient/parental interview).
• Current participation in another clinical trial.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (2)

Plateforme CENIR_PANAM au centre de Neuro Imagerie de recherche à l' " Institut du Cerveau " (ICM)

Paris, 75013, France

Location

Hôpital Necker - Enfants Malades - Service de radiologie pédiatrique

Paris, 75015, France

Location

Related Publications (2)

• Ameis SH, Blumberger DM, Croarkin PE, Mabbott DJ, Lai MC, Desarkar P, Szatmari P, Daskalakis ZJ. Treatment of Executive Function Deficits in autism spectrum disorder with repetitive transcranial magnetic stimulation: A double-blind, sham-controlled, pilot trial. Brain Stimul. 2020 May-Jun;13(3):539-547. doi: 10.1016/j.brs.2020.01.007. Epub 2020 Jan 15.

  PMID: 32289673 BACKGROUND

• Abujadi C, Croarkin PE, Bellini BB, Brentani H, Marcolin MA. Intermittent theta-burst transcranial magnetic stimulation for autism spectrum disorder: an open-label pilot study. Braz J Psychiatry. 2018 Jul-Sep;40(3):309-311. doi: 10.1590/1516-4446-2017-2279. Epub 2017 Dec 11.

  PMID: 29236921 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Eye-Tracking Technology

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Eye Movement Measurements; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Monica ZILBOVICIUS, PhD

  INSERM INSERM ERL "Trajectoires Développementales en Psychiatrie" Service de Radiologie Pédiatrique Hospital Necker Enfants Malades

  STUDY CHAIR

• Nathalie BODDAERT, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie BODDAERT, MD, PhD

CONTACT

0171396530; nathalie.boddaert@aphp.fr

Laure Choupeaux, MSc

CONTACT

0144381711; laure.choupeaux@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 18, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

FR (2)