Autism Spectrum Disorders: Double Blind Randomized Placebo-control Active Pilot Study of Transcranial Magnetic Stimulation Applied to the Superior Temporal Sulcus
Assistance Publique - Hôpitaux de Paris
20 participants
Feb 2, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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.
Exclusion Criteria8
- 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.
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Interventions
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
Anatomical and functional images will be acquired and review by an experienced neuro-radiologist.
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 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
The DNA will be extracted from the salivary sample to genotyping analyses on the BDNF (Val66Met) and COMT (Val158Met) polymorphism
CGI, E-CAR and ABC will be used for behavior and clinical evaluation
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04442061