Status:
RECRUITING
Autism Spectrum Disorders: Double Blind Randomized Placebo-control Active Pilot Study of Transcranial Magnetic Stimulation Applied to the Superior Temporal Sulcus
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Fondation de France
Fondation Malakoff Médéric
Conditions:
Autism Spectrum Disorders
Eligibility:
All Genders
17-25 years
Phase:
PHASE2
Brief Summary
Difficulties in social interactions are the core feature of autism spectrum disorder (ASD) and are characterized by abnormal social perception, mainly concerning eye gaze. Anatomo-functional abnormali...
Detailed Description
Autism Spectrum Disorders (ASD) are neuro-developmental disorders presumably related to neural circuit alterations. The symptoms, that start very early in development and persist through adulthood, ca...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female patient diagnosed with ASD according to DSM-V and ADI-R
- Patient aged 17 to 25
- Patient apt to undergo an MRI
- Patient affiliated with a social security system or beneficiary of such system
- Informed consent signed by the patient or his legal guardian.
- Exclusion Criteria :
- Presence of a somatic pathology
- Presence of a neurological pathology
- Presence of epilepsy, history of seizure.
- Initiation, discontinuation or modification of neuroleptics or benzodiazepines treatment in the previous month
- Contraindication to MRI (pacemaker, intracorporeal metallic foreign body, metal worker)
- Contraindication to the use of TMS (epilepsy and family epilepsy, presence of craniotomy scar, pacemaker or pacemaker, intraocular or intracerebral metallic foreign body, cochlear implant, cardiac valve or metallic surgical arterial material, metallic material capable of concentrating radio frequency pulses)
- Pregnancy and breast-feeding
- Participation in another pilot study or clinical trial that does not allow participation in this protocol.
Exclusion
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04442061
Start Date
February 2 2022
End Date
December 1 2026
Last Update
November 20 2025
Active Locations (1)
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1
Hôpital Necker Enfants Malades - Service de radiologie pédiatrique
Paris, France, 75015