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NCT04442061CompletedPhase 2

Autism Spectrum Disorders: Double Blind Randomized Placebo-control Active Pilot Study of Transcranial Magnetic Stimulation Applied to the Superior Temporal Sulcus

Source: ClinicalTrials.gov · Last updated 1 May 2026

Brief summary (registry, in English)

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 abnormalities within the superior temporal sulcus (STS), a key region of the social brain, have been described in ASD. The investigators had recently shown that it is possible to modulate the neural activity of the STS with transcranial magnetic stimulation (TMS) with an impact on social perception, measured by eye-tracking. In the context of ASD, stimulation of the STS with excitatory TMS could lead to an improvement in social perception, which would open up new therapeutic strategies. The purpose of this double-blind, randomized, placebo-controlled study is to apply a therapeutic TMS protocol (10 daily sessions) at the right STS in young adults with ASD to improve their social behavior, objectively measured using eye-tracking.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
20 (actual)
First submitted
20 Apr 2020
Start date
2 Feb 2022
Primary completion date
22 Jan 2026
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Diseases
Autism
NCT number
NCT04442061

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 20
  • From 2 Feb 2022 to the primary completion date, 22 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Initiation, discontinuation or modification of neuroleptics or benzodiazepines treatment in the previous month

Other illness

  • Presence of epilepsy, history of seizure.
  • 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)

Other

  • Presence of a somatic pathology
  • Presence of a neurological pathology
  • Contraindication to MRI (pacemaker, intracorporeal metallic foreign body, metal worker)
  • Pregnancy and breast-feeding
  • Participation in another pilot study or clinical trial that does not allow participation in this protocol.

Who the study is looking for

  • 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.

Age in the registry: 17 years to 25 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hôpital Necker - Enfants Malades - Service de radiologie pédiatrique
Coordinator of this site? Confirm its status
ParisFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.