Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01648868
Recruitment Status : Unknown
Verified November 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : July 24, 2012
Last Update Posted : November 27, 2017
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Device: Transcranial Magnetic Stimulation (rTMS) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation (rTMS) and Autism.Implication of the Superior Temporal Sulcus in Normal and Abnormal Social Perception
Actual Study Start Date : April 6, 2011
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

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.

Active Comparator: Inhibitory effects of rTMS
Study inhibitory effects of rTMS applied to the STS in healthy controls
Device: Transcranial Magnetic Stimulation (rTMS)
Inhibitory effects of Transcranial Magnetic Stimulation (rTMS) applied to the STS in healthy controls

Primary Outcome Measures :
  1. Fixation time in eyes, mouth and face areas [ Time Frame: 1 day ]
    Fixation time in eyes, mouth and face areas during the presentation of social scenes

Secondary Outcome Measures :
  1. Eye-tracking or voice human perception correlation [ Time Frame: 1 day ]
    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.

  2. Fractional anisotropy covariation [ Time Frame: 1 day ]
    Covariation of fractional anisotropy (FA) with data from eye-tracking or human voice perception (before and after TMS)

  3. Fractional anisotropy comparison [ Time Frame: 1 day ]
    Comparison of fractional anisotropy (FA) between autistic patients and healthy controls

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01648868

Layout table for location contacts
Contact: Nathalie BODDAERT, MD, PhD ++33144494738
Contact: Beatrice BARBIER ++33144495969

Layout table for location information
Hôpital Necker-Enfants Malades Recruiting
Paris, France, 75015
Contact: Nathalie BODDAERT, MD, PhD    ++33144494738   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01648868     History of Changes
Other Study ID Numbers: P 081232
2009-A01025-52 ( Registry Identifier: ID RCB )
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Social perception
Social cognition
Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders