CompletedPhase 2

Autism Spectrum Disorders: Double Blind Randomized Placebo-control Active Pilot Study of Transcranial Magnetic Stimulation Applied to the Superior Temporal Sulcus

France20 participantsStarted 2022-02-02

Plain-language summary

Difficulties in social interactions are the core feature of autism spectrum disorder (ASD) and are characterized by abnormal social perception, mainly concerning eye gaze. Anatomo-functional abnormalities within the superior temporal sulcus (STS), a key region of the social brain, have been described in ASD. The investigators had recently shown that it is possible to modulate the neural activity of the STS with transcranial magnetic stimulation (TMS) with an impact on social perception, measured by eye-tracking. In the context of ASD, stimulation of the STS with excitatory TMS could lead to an improvement in social perception, which would open up new therapeutic strategies. The purpose of this double-blind, randomized, placebo-controlled study is to apply a therapeutic TMS protocol (10 daily sessions) at the right STS in young adults with ASD to improve their social behavior, objectively measured using eye-tracking.

Who can participate

Age range17 Years – 25 Years

SexALL

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Inclusion Criteria: * Male or female patient diagnosed with ASD according to DSM-V and ADI-R * Patient aged 17 to 25 * Patient apt to undergo an MRI * Patient affiliated with a social security system or beneficiary of such system * Informed consent signed by the patient or his legal guardian. Exclusion Criteria : * Presence of a somatic pathology * Presence of a neurological pathology * Presence of epilepsy, history of seizure. * Initiation, discontinuation or modification of neuroleptics or benzodiazepines treatment in the previous month * Contraindication to MRI (pacemaker, intracorporeal metallic foreign body, metal worker) * Contraindication to the use of TMS (epilepsy and family epilepsy, presence of craniotomy scar, pacemaker or pacemaker, intraocular or intracerebral metallic foreign body, cochlear implant, cardiac valve or metallic surgical arterial material, metallic material capable of concentrating radio frequency pulses) * Pregnancy and breast-feeding * Participation in another pilot study or clinical trial that does not allow participation in this protocol.

What they're measuring

Changes gaze pattern to the eyes

Timeframe: Until 3 months after iTBS sessions

Trial details

NCT IDNCT04442061

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-22