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

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 2, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

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

Trial Locations (1)

75015

RECRUITING

Hôpital Necker Enfants Malades - Service de radiologie pédiatrique, Paris

All Listed Sponsors
collaborator

Fondation de France

OTHER

collaborator

Fondation Malakoff Médéric

UNKNOWN

lead

Assistance Publique - Hôpitaux de Paris

OTHER