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

Who is this study for? Patients with autism spectrum disorders
What treatments are being studied? Transcranial magnetic stimulation+MRI+Neuronavigation+Eye-tracking+Salivary samples+Clinical scales
Status: Recruiting
Location: See location...
Intervention Type: Device, Other, Genetic
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 17
Maximum Age: 25
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Hôpital Necker Enfants Malades - Service de radiologie pédiatrique
RECRUITING
Paris
Contact Information
Primary
Nathalie BODDAERT, MD, PhD
nathalie.boddaert@aphp.fr
+33171396530
Backup
Laure CHOUPEAUX, Master
laure.choupeaux@aphp.fr
+33144381711
Time Frame
Start Date: 2022-02-02
Estimated Completion Date: 2026-12
Participants
Target number of participants: 20
Treatments
Active_comparator: Active transcranial magnetic stimulation
excitatory TMS will be applied to the right posterior STS
Sham_comparator: Sham transcranial magnetic stimulation
The sham TMS follows the same procedure of the active TMS without stimulating cortical tissue
Related Therapeutic Areas
Sponsors
Collaborators: Fondation Malakoff Médéric, Fondation de France
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov