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.
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
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)
Crossover
Neuromodulation by transcranial magnetic stimulation (TMS)
Device2 series of 5 TMS applied each day, during 4 consecutive days : active or sham according randomization
Anatomo-functional MRI
RadiationFor 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.
Eye-tracking
DeviceEye-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.
Social Responsiveness Scale, Second Edition (SRS-2)
Other interventionA 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.
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.
Change in resting cerebral blood flow
Change in rest cerebral blood flow (CBF) following active versus sham iTBS targeting the right posterior superior temporal sulcus, assessed using arterial spin labeling magnetic resonance imaging (ASL-MRI).
Change in resting-state functional connectivity
Change in resting-state functional brain connectivity following active versus sham iTBS targeting the right posterior superior temporal sulcus, assessed using resting-state functional magnetic resonance imaging (rs-fMRI).
Change in white matter microstructure
Change in white matter microstructural integrity following active versus sham iTBS targeting the right posterior superior temporal sulcus, assessed using diffusion-weighted magnetic resonance imaging (DWI-MRI)
Change in social responsiveness assessed by the SRS-2
Change in social functioning following active versus sham iTBS, assessed using the Social Responsiveness Scale, Second Edition (SRS-2), completed with the participant's parents.
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
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