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Autism Spectrum DisorderTMSAUTISMENCT01648868

Transcranial Magnetic Stimulation (rTMS) and Autism.

A study testing Transcranial Magnetic Stimulation (rTMS) in people with Autism Spectrum Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Transcranial Magnetic Stimulation (rTMS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
1 siteFrance
Study dates
6 Apr 2011to 13 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hôpital Necker-Enfants Malades

    Paris, 75015

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Transcranial Magnetic Stimulation (rTMS)
Keywords
TMSAutism, Eye-tracking, Social perception, Social cognition
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Magnetic Stimulation (rTMS)Device

    Excitatory effects of Transcranial Magnetic Stimulation (rTMS) applied to the STS in patients with autism.

  • Transcranial Magnetic Stimulation (rTMS)Device

    Inhibitory effects of Transcranial Magnetic Stimulation (rTMS) applied to the STS in healthy controls

Study groups in NCT01648868
Study groupRoleWhat they receive
Excitatory effects of rTMSExperimentalStudy excitatory effects of rTMS applied to the STS in patients with autism
Receives: Device: Transcranial Magnetic Stimulation (rTMS)
Inhibitory effects of rTMSActive comparatorStudy inhibitory effects of rTMS applied to the STS in healthy controls
Receives: Device: Transcranial Magnetic Stimulation (rTMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fixation time in eyes, mouth and face areas

    Fixation time in eyes, mouth and face areas during the presentation of social scenes

    Measured: 1 day

Secondary outcomes (3)
  1. 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.

    Measured: 1 day

  2. Fractional anisotropy covariation

    Covariation of fractional anisotropy (FA) with data from eye-tracking or human voice perception (before and after TMS)

    Measured: 1 day

  3. Fractional anisotropy comparison

    Comparison of fractional anisotropy (FA) between autistic patients and healthy controls

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2012 (estimated)
  2. Study start6 Apr 2011
  3. Primary completion27 Sep 2017
  4. Study completion13 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01648868
Sponsor's protocol ID
P081232
Other IDs
2009-A01025-52
Acronym
TMSAUTISME
Status last verified
Sep 2025
First submitted
20 Jul 2012
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26946130
  • 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.

    PubMed 31239453

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Magnetic Stimulation (rTMS) in people with Autism Spectrum Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fixation time in eyes, mouth and face areas (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01648868, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.

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