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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04442061
Other study ID # APHP191009
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 2, 2022
Est. completion date October 2025

Study information

Verified date July 2023
Source Assistance Publique - Hôpitaux de Paris
Contact Nathalie BODDAERT, MD, PhD
Phone +33171396530
Email nathalie.boddaert@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
France Hôpital Necker Enfants Malades - Service de radiologie pédiatrique Paris

Sponsors (3)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Fondation de France, Fondation Malakoff Médéric

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Autistic Behavior Checklist (ABC) scale at v1 Evaluate social behavior and autistic symptoms (Lower score = 0 Higher score mean worse outcome = 174) 5 days before iTBS sessions
Secondary Autistic Behavior Checklist (ABC) scale at v2 Evaluate social behavior and autistic symptoms (Lower score = 0 Higher score mean worse outcome = 174) 5 days after iTBS sessions
Secondary Autistic Behavior Checklist (ABC) scale at v3 Evaluate social behavior and autistic symptoms (Lower score = 0 Higher score mean worse outcome = 174) 1 month after iTBS sessions
Secondary Autistic Behavior Checklist (ABC) scale at v4 Evaluate social behavior and autistic symptoms (Lower score = 0 Higher score mean worse outcome = 174) 3 months after iTBS sessions
Secondary "Evaluation des comportements Autistiques révisée" (ECA-R) scale at v1 Evaluate social behavior and autistic symptoms (Lower score = 0 Higher score mean worse outcome = 116) 5 days before iTBS sessions
Secondary "Evaluation des comportements Autistiques révisée"(ECA-R) scale at v2 Evaluate social behavior and autistic symptoms (Lower score = 0 Higher score mean worse outcome = 116) 5 days after iTBS sessions
Secondary "Evaluation des comportements Autistiques révisée" (ECA-R) scale at v3 Evaluate social behavior and autistic symptoms (Lower score = 0 Higher score mean worse outcome = 116) 1 month after iTBS sessions
Secondary "Evaluation des comportements Autistiques révisée" (ECA-R) scale at v4 Evaluate social behavior and autistic symptoms (Lower score = 0 Higher score mean worse outcome = 116) 3 months after iTBS sessions
Secondary Clinical Global Impression (CGI) scale at v1 global functioning (Lower score = 1 Higher score mean worse outcome=16) 5 days before iTBS sessions
Secondary Clinical Global Impression (CGI) scale at v2 global functioning (Lower score = 1 Higher score mean worse outcome=16) 5 days after iTBS sessions
Secondary Clinical Global Impression (CGI) scale at v3 global functioning (Lower score = 1 Higher score mean worse outcome=16) 1 month after iTBS sessions
Secondary Clinical Global Impression (CGI) scale at v4 global functioning (Lower score = 1 Higher score mean worse outcome=16) 3 months after iTBS sessions
Secondary Changes in rest brain fonctionning at v1 by measuring whole brain cerebral blood flow at rest using MRI-ASL 5 days before iTBS sessions
Secondary Changes in rest brain fonctioning at v2 by measuring whole brain cerebral blood flow at rest using MRI-ASL 5 days after iTBS sessions
Secondary Changes in rest brain fonctioning at v4 by measuring whole brain cerebral blood flow at rest using MRI-ASL 3 months after iTBS sessions
Secondary Putative changes on brain functional connectivity at rest at V1 by using the resting state sequence using MRI-ASL 5 days before iTBS sessions
Secondary Putative changes on brain functional connectivity at rest at V2 by using the resting state sequence using MRI-ASL 5 days after iTBS sessions
Secondary Putative changes on brain functional connectivity at V4 by using the resting state sequence using MRI-ASL 3 months after iTBS sessions
Secondary Anatomical connectivity abnormalities by using the diffusion tensor imaging sequence (DTI) using MRI-ASL At V1 : 5 days before iTBS sessions
Secondary BDNF/COMT polymorphisms Research of BDNF/COMT polymorphisms on salivary samples 5 days after baseline
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