Transcranial Magnetic Stimulation (rTMS) and Autism. (TMSAUTISME)

Transcranial Magnetic Stimulation (rTMS) and Autism.Implication of the Superior Temporal Sulcus in Normal and Abnormal Social Perception

In this protocol we aim to use rTMS to better characterize STS role in normal and abnormal social cognition. With that purpose, we will measure the effect of inhibitory and excitatory rTMS on the fixation time on social scenes (using eye-tracking methodology) or on the ability to recognize human voice/sounds.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation (rTMS); Device: Transcranial Magnetic Stimulation (rTMS)

Detailed Description

Autism is characterized by severe impairments in verbal and non verbal communication and in social interactions. Results from cerebral imaging studies have suggested that abnormalities located on the superior temporal Sulcus (STS) level would be implicated in social impairments in autism. This abnormalities are both anatomical and functional: 1) rest hypoperfusion detected by positron emission tomography (PET); 2) abnormal activation during social tasks (fMRI) and 3) structural abnormalities shown on anatomical MRI. The STS is implicated in social cognition in normal subjects. Our hypothesis is that these anatomo-functional abnormalities would appear very early in brain development and could be one of the first steps in the cascade of neuronal dysfunction in autism. Transcranial Magnetic Stimulation (rTMS) is a technique which is used in cognitive neuroscience research as well as in therapeutic approaches in certain neurological and psychiatry diseases. It consists on applying a magnetic impulse on the brain trough the scalp in a non-invasive and painless by placing a coil on the surface of the head. This magnetic fields induce an electrical field which modifies activity of those neurons inside the magnetic field and induce an electrophysiological change in the target area. This process allows a non-invasive interaction with the human brain in action during focal stimulations. In cognitive neuroscience research, we are interested in the modifications caused by rTMS in cognitive performances in order to better precise the functional role of the target region. The intensity and the frequency of the impulse can be controlled (frequency <1 Hz = inhibitory effect ; frequency > 3 Hz = excitatory effect). The functional characteristics of a given region and it's eventual dysfunctions may be identified thank to the abnormalities in reactivity and cortical connectivity. The goal of this project is to study inhibitory and excitatory effects of rTMS applied to the STS in healthy controls and patients with autism. This effect will be measured by two main parameters of social cognition: 1) visual perception of social scenes, measured by eye-tracking methodology; 2) auditory perception of human voice. We will study 50 healthy voluntaries controls and 50 patients with a non-syndromic autism (18 to 25 years old; IQ > 60), diagnosed by DSM-IV and ADI-R. All participants will undergo an structural MRI and a rTMS session on the STS. In both cases, the STS will be localised based on the structural MRI. The total duration of the rTMS session is about two hours. All data will be analysed by the adapted statistical methods. This study will allow a better understanding of the role of STS in social cognition in healthy subjects as well as it's implication in the social impairments which characterize autism. Finally, the rTMS may become, in a near future, a innovative therapeutic strategy in autism.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hôpital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 26 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Patients with autism

• Age from 18 to 30 years old
• Autism diagnosed by DSM-IV and ADI-R
• IQ > 60 or able to have an MRI
• Social security registration
• Consent form signed by patient or legal tutor

Healthy controls

• Age from 18 to 30 years old
• Medical exam previous to the interventions
• Social security registration
• Consent form signed

Exclusion Criteria:

All Patients

• Indication against MRI (pace-maker, metallic pieces in the body, working with metals)
• Indications against rTMS (epilepsy, epilepsy family history, craniotomy scarf, pace maker or neuron stimulator, intraocular or intra-cerebral strange metallic piece, cochlear implant, cardiac valve, chirurgical metallic arterial material, metallic material susceptible to concentrate radio-frequency impulse)
• Claustrophobia
• Pregnant woman
• Women in a fertile age with no efficient contraception method
• Use of drugs diminishing cortical excitability
• Participation in another clinical trial that forbids the participation in this one
• Have already being treated by some electrical or magnetic stimulation technique ( transcutaneous or radicular stimulation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Excitatory effects of rTMS; Study excitatory effects of rTMS applied to the STS in patients with autism	Device: Transcranial Magnetic Stimulation (rTMS); Excitatory effects of Transcranial Magnetic Stimulation (rTMS) applied to the STS in patients with autism.; Device: Transcranial Magnetic Stimulation (rTMS); Inhibitory effects of Transcranial Magnetic Stimulation (rTMS) applied to the STS in healthy controls
Active Comparator: Inhibitory effects of rTMS; Study inhibitory effects of rTMS applied to the STS in healthy controls	Device: Transcranial Magnetic Stimulation (rTMS); Excitatory effects of Transcranial Magnetic Stimulation (rTMS) applied to the STS in patients with autism.; Device: Transcranial Magnetic Stimulation (rTMS); Inhibitory effects of Transcranial Magnetic Stimulation (rTMS) applied to the STS in healthy controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fixation time in eyes, mouth and face areas	Fixation time in eyes, mouth and face areas during the presentation of social scenes	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eye-tracking or voice human perception correlation	Data from eye-tracking or voice human perception (before and after Transcranial Magnetic Stimulation - TMS) will be correlated to different scores of Autism Diagnostic Interview (ADI) : social, communication and repetitive behaviours.	1 day
Fractional anisotropy covariation	Covariation of fractional anisotropy (FA) with data from eye-tracking or human voice perception (before and after TMS)	1 day
Fractional anisotropy comparison	Comparison of fractional anisotropy (FA) between autistic patients and healthy controls	1 day

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Unité de Recherche Clinique Necker Cochin, France
• Investigators: Principal Investigator: Nathalie BODDAERT, MD, PhD, Necker-Enfants Malades Hospital; Study Director: Monica ZILBOVICIUS, PhD, Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

General Publications

• Saitovitch A, Lemaitre H, Rechtman E, Vincon-Leite A, Calmon R, Grevent D, Dangouloff-Ros V, Brunelle F, Boddaert N, Zilbovicius M. Neural and behavioral signature of human social perception. Sci Rep. 2019 Jun 25;9(1):9252. doi: 10.1038/s41598-019-44977-8.
• Saitovitch A, Popa T, Lemaitre H, Rechtman E, Lamy JC, Grevent D, Calmon R, Meunier S, Brunelle F, Samson Y, Boddaert N, Zilbovicius M. Tuning Eye-Gaze Perception by Transitory STS Inhibition. Cereb Cortex. 2016 Jun;26(6):2823-31. doi: 10.1093/cercor/bhw045. Epub 2016 Mar 5.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2011
• Primary Completion (Actual): September 27, 2017
• Study Completion (Actual): May 13, 2019

Study Registration Dates

• First Submitted: July 20, 2012
• First Submitted That Met QC Criteria: July 20, 2012
• First Posted (Estimated): July 24, 2012

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 1, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Social perception; Social cognition; Eye-tracking; TMSAutism
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Therapeutics; Magnetic Field Therapy; Transcranial Magnetic Stimulation
• Other Study ID Numbers: P081232; 2009-A01025-52 (Registry Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO