Transcranial Magnetic Stimulation (rTMS) and Autism. (TMSAUTISME)
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (rTMS)
Transcranial Magnetic Stimulation (rTMS)
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring TMSAutism, Eye-tracking, Social perception, Social cognition
Eligibility Criteria
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)
Sites / Locations
- Hôpital Necker-Enfants Malades
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Excitatory effects of rTMS
Inhibitory effects of rTMS
Arm Description
Study excitatory effects of rTMS applied to the STS in patients with autism
Study inhibitory effects of rTMS applied to the STS in healthy controls
Outcomes
Primary Outcome Measures
Fixation time in eyes, mouth and face areas
Fixation time in eyes, mouth and face areas during the presentation of social scenes
Secondary Outcome Measures
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.
Fractional anisotropy covariation
Covariation of fractional anisotropy (FA) with data from eye-tracking or human voice perception (before and after TMS)
Fractional anisotropy comparison
Comparison of fractional anisotropy (FA) between autistic patients and healthy controls
Full Information
NCT ID
NCT01648868
First Posted
July 20, 2012
Last Updated
March 19, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01648868
Brief Title
Transcranial Magnetic Stimulation (rTMS) and Autism.
Acronym
TMSAUTISME
Official Title
Transcranial Magnetic Stimulation (rTMS) and Autism.Implication of the Superior Temporal Sulcus in Normal and Abnormal Social Perception
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 6, 2011 (Actual)
Primary Completion Date
September 27, 2017 (Actual)
Study Completion Date
May 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
TMSAutism, Eye-tracking, Social perception, Social cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Excitatory effects of rTMS
Arm Type
Experimental
Arm Description
Study excitatory effects of rTMS applied to the STS in patients with autism
Arm Title
Inhibitory effects of rTMS
Arm Type
Active Comparator
Arm Description
Study inhibitory effects of rTMS applied to the STS in healthy controls
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (rTMS)
Intervention Description
Excitatory effects of Transcranial Magnetic Stimulation (rTMS) applied to the STS in patients with autism.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (rTMS)
Intervention Description
Inhibitory effects of Transcranial Magnetic Stimulation (rTMS) applied to the STS in healthy controls
Primary Outcome Measure Information:
Title
Fixation time in eyes, mouth and face areas
Description
Fixation time in eyes, mouth and face areas during the presentation of social scenes
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Eye-tracking or voice human perception correlation
Description
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.
Time Frame
1 day
Title
Fractional anisotropy covariation
Description
Covariation of fractional anisotropy (FA) with data from eye-tracking or human voice perception (before and after TMS)
Time Frame
1 day
Title
Fractional anisotropy comparison
Description
Comparison of fractional anisotropy (FA) between autistic patients and healthy controls
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie BODDAERT, MD, PhD
Organizational Affiliation
Necker-Enfants Malades Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Monica ZILBOVICIUS, PhD
Organizational Affiliation
Institut National de la Santé Et de la Recherche Médicale, France
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transcranial Magnetic Stimulation (rTMS) and Autism.
We'll reach out to this number within 24 hrs