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

NCT04442061 | Completed Phase 2

• 1 other identifier: APHP191009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Autism Spectrum Disorders

Keywords

transcranial magnetic stimulation; superior temporal sulcus

Outcome Measures

Primary Outcomes (1)

• Changes gaze pattern to the eyes

  Changes number of fixations to the eyes measured by eye-tracking during passive visualization of social scenes following the 10 iTBS sessions applied to the right pSTS compared to baseline measures.

  Until 3 months after iTBS sessions

Secondary Outcomes (20)

• Autistic Behavior Checklist (ABC) scale at v1

  5 days before iTBS sessions

• Autistic Behavior Checklist (ABC) scale at v2

  5 days after iTBS sessions

• Autistic Behavior Checklist (ABC) scale at v3

  1 month after iTBS sessions

• Autistic Behavior Checklist (ABC) scale at v4

  3 months after iTBS sessions

• "Evaluation des comportements Autistiques révisée" (ECA-R) scale at v1

  5 days before iTBS sessions

Study Arms (2)

Active transcranial magnetic stimulation

ACTIVE COMPARATOR

excitatory TMS will be applied to the right posterior STS

Device: Transcranial magnetic stimulation; Device: MRI; Device: Neuronavigation; Device: Eye-tracking; Genetic: Salivary samples; Other: Clinical scales

Sham transcranial magnetic stimulation

SHAM COMPARATOR

The sham TMS follows the same procedure of the active TMS without stimulating cortical tissue

Device: Transcranial magnetic stimulation; Device: MRI; Device: Neuronavigation; Device: Eye-tracking; Genetic: Salivary samples; Other: Clinical scales

Interventions

Transcranial magnetic stimulation DEVICE

Before the stimulation, identification of a motor "hotspot" and active motor threshold (AMT) will be performed. The TMS will be applied on the intermittent theta-burst modality (iTBS), i. e., 2 s of TBS trains (30 pulses) repeated every 10 s for 190 s, with a total number of 600 pulses (Huang et al, 2005). The whole TMS session, including preparation, will last up to 1h. The sham TMS follows the same procedure of the active TMS without stimulating cortical tissue

Active transcranial magnetic stimulation; Sham transcranial magnetic stimulation

MRI DEVICE

Anatomical and functional images will be acquired and review by an experienced neuro-radiologist.

Active transcranial magnetic stimulation; Sham transcranial magnetic stimulation

Neuronavigation DEVICE

The neuronavigation system will allow to guide the stimulation using the individual anatomical MRI acquired with MRI, and to record the position and orientation of the coil during successive stimulations

Active transcranial magnetic stimulation; Sham transcranial magnetic stimulation

Eye-tracking DEVICE

Eye movements and follow a person's gaze will be recorded during visualization of stimuli presented in the screen by analyzing images of the eye captured by an infrared camera

Active transcranial magnetic stimulation; Sham transcranial magnetic stimulation

Salivary samples GENETIC

The DNA will be extracted from the salivary sample to genotyping analyses on the BDNF (Val66Met) and COMT (Val158Met) polymorphism

Active transcranial magnetic stimulation; Sham transcranial magnetic stimulation

Clinical scales OTHER

CGI, E-CAR and ABC will be used for behavior and clinical evaluation

Active transcranial magnetic stimulation; Sham transcranial magnetic stimulation

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fondation de France: collaborator
• Fondation Malakoff Médéric: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker Enfants Malades - Service de radiologie pédiatrique

Paris, 75015, France

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Transcranial Magnetic Stimulation; Neuronavigation; Eye-Tracking Technology

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Surgery, Computer-Assisted; Investigative Techniques; Eye Movement Measurements; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Monica ZILBOVICIUS

  INSERM ERL "Trajectoires Developpementales en Psychiatrie"

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: June 22, 2020
• Study Start: February 2, 2022
• Primary Completion: January 22, 2026
• Study Completion: January 23, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)