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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01648868
First received: July 20, 2012
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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 Intervention
Autism Spectrum Disorder
Device: Transcranial Magnetic Stimulation (rTMS)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Fixation time in eyes, mouth and face areas [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Fixation time in eyes, mouth and face areas during the presentation of social scenes

  • Rate of human voice perception/identification. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Rate of human voice perception/identification.


Secondary Outcome Measures:
  • Eye-tracking or voice human perception correlation [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.

  • Fractional anisotropy covariation [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Covariation of fractional anisotropy (FA) with data from eye-tracking or human voice perception (before and after TMS)

  • Fractional anisotropy comparison [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Comparison of fractional anisotropy (FA) between autistic patients and healthy controls


Estimated Enrollment: 150
Study Start Date: April 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients with autism

  • Age from 18 to 30 years old
  • Autism diagnosed by DSM-IV and ADI-R
  • IQ > 60
  • 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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648868

Contacts
Contact: Nathalie BODDAERT, MD, PhD ++33144494738 nathalie.boddaert@nck.aphp.fr
Contact: Laurence LECOMTE, PhD ++33171196494 laurence.lecomte@nck.aphp.fr

Locations
France
Hôpital Necker-Enfants Malades Recruiting
Paris, France, 75015
Contact: Nathalie BODDAERT, MD, PhD    ++33144494738    nathalie.boddaert@nck.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Nathalie BODDAERT, MD, PhD Necker-Enfants Malades Hospital
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01648868     History of Changes
Other Study ID Numbers: P 081232, 2009-A01025-52
Study First Received: July 20, 2012
Last Updated: June 20, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
TMSAutism
Eye-tracking
Social perception
Social cognition

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014