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Autism Spectrum Disorders: Double Blind Randomized Placebo-control Active Pilot Study of Transcranial Magnetic Stimulation Applied to the Superior Temporal Sulcus
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
Key Details
Gender
All
Age Range
17 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2022-02-02
Completion Date
2026-12
Last Updated
2025-11-20
Healthy Volunteers
No
Conditions
Interventions
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
MRI
Anatomical and functional images will be acquired and review by an experienced neuro-radiologist.
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
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
Salivary samples
The DNA will be extracted from the salivary sample to genotyping analyses on the BDNF (Val66Met) and COMT (Val158Met) polymorphism
Clinical scales
CGI, E-CAR and ABC will be used for behavior and clinical evaluation
Locations (1)
Hôpital Necker Enfants Malades - Service de radiologie pédiatrique
Paris, France