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Interventional rTMS for Improving Social Perception in Autism

Study acronym: IRIS-gaze
StatusNot Yet Recruiting
PhaseNot applicable
Started2026-10
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07828457
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: URC-CIC Paris Descartes Necker Cochin
Conditions Autism Spectrum Disorders (ASD)
Enrollment 16 participants
Start Date 2026-10
Primary Completion 2028-11 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-18