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

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

Interventions

DEVICE

Transcranial magnetic stimulation

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

DEVICE

MRI

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

DEVICE

Neuronavigation

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

DEVICE

Eye-tracking

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

GENETIC

Salivary samples

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

OTHER

Clinical scales

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

Sponsors & Collaborators

• Fondation de France

  collaborator OTHER

• Fondation Malakoff Médéric

  collaborator UNKNOWN

• URC-CIC Paris Descartes Necker Cochin

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Monica ZILBOVICIUS · INSERM ERL "Trajectoires Developpementales en Psychiatrie"

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

17 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-02

Primary Completion

2026-01-22

Completion

2026-01-23

Countries

• France

Study Locations