Transcranial magnetic stimulation for improving social perception in autism
Autism Spectrum Disorders: Double Blind Randomized Placebo-control Active Pilot Study of Transcranial Magnetic Stimulation Applied to the Superior Temporal Sulcus
PHASE2 · Assistance Publique - Hôpitaux de Paris · NCT04442061
This study is testing if a special brain treatment can help young adults with autism improve their social skills and interactions.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 17 Years to 25 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT04442061 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of transcranial magnetic stimulation (TMS) applied to the superior temporal sulcus (STS) in young adults diagnosed with autism spectrum disorders (ASD). The study involves 10 daily sessions of excitatory TMS aimed at enhancing social behavior, which will be objectively measured through eye-tracking technology. By targeting the STS, a critical region for social perception, the researchers aim to modulate neural activity and improve social interactions in participants. The study is double-blind and placebo-controlled to ensure the reliability of results.
Who should consider this trial
Good fit: Ideal candidates for this study are young adults aged 17 to 25 who have been diagnosed with autism spectrum disorder.
Not a fit: Patients with neurological conditions, epilepsy, or contraindications to MRI or TMS will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance social perception and interactions in individuals with autism spectrum disorders.
How similar studies have performed: While the application of TMS in this context is relatively novel, previous studies have shown promising results in modulating social perception in individuals with ASD.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria : * 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.
Where this trial is running
Paris
- Hôpital Necker Enfants Malades - Service de radiologie pédiatrique — Paris, France (RECRUITING)
Study contacts
- Study coordinator: Nathalie BODDAERT, MD, PhD
- Email: nathalie.boddaert@aphp.fr
- Phone: +33171396530
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism Spectrum Disorders, transcranial magnetic stimulation, superior temporal sulcus