NCT01648868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2017

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2019

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

6.5 years

First QC Date

July 20, 2012

Last Update Submit

September 1, 2025

Conditions

Autism Spectrum Disorder

Keywords

TMSAutismEye-trackingSocial perceptionSocial cognition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Eye-tracking or voice human perception correlation

    1 day

  • Fractional anisotropy covariation

    1 day

  • Fractional anisotropy comparison

    1 day

Study Arms (2)

Excitatory effects of rTMS

EXPERIMENTAL

Study excitatory effects of rTMS applied to the STS in patients with autism

Device: Transcranial Magnetic Stimulation (rTMS)

Inhibitory effects of rTMS

ACTIVE COMPARATOR

Study inhibitory effects of rTMS applied to the STS in healthy controls

Device: Transcranial Magnetic Stimulation (rTMS)

Interventions

Transcranial Magnetic Stimulation (rTMS)DEVICE

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

Excitatory effects of rTMS

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (2)

  • 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.

    PMID: 26946130BACKGROUND

  • 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.

    PMID: 31239453BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Nathalie BODDAERT, MD, PhD

    Necker-Enfants Malades Hospital

    PRINCIPAL INVESTIGATOR

  • Monica ZILBOVICIUS, PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2012

First Posted

July 24, 2012

Study Start

April 6, 2011

Primary Completion

September 27, 2017

Study Completion

May 13, 2019

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)