Using magnetic stimulation to improve symptoms in children with autism
Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorders: a Multicenter, Randomized Controlled Trial
This study is testing whether a new type of magnetic brain stimulation can help improve symptoms in children aged 4 to 10 with autism.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 4 Years to 10 Years |
| Sex | All |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 3 sites (Zhengzhou, Henan and 2 other locations) |
| Trial ID | NCT05927792 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multicenter, randomized, single-blind controlled trial aimed at evaluating the efficacy of accelerated continuous theta-burst stimulation (a-cTBS) on children diagnosed with autism spectrum disorders (ASD). A total of 200 children aged 4-10 years will be enrolled and randomly assigned to either an intervention group receiving real stimulation or a sham group receiving pseudo-stimulation. The study will assess the impact of the intervention on core symptoms of ASD through clinical evaluations conducted before, immediately after, and one month following the treatment. The trial aims to provide insights into the effectiveness of this novel approach based on previous findings.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4-10 years who meet the DSM-5 diagnostic criteria for autism spectrum disorders and have an IQ of 50 or above.
Not a fit: Patients with neurological disorders, serious heart disease, or those who have received other interventions recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve social and language functions in children with autism spectrum disorders.
How similar studies have performed: Previous studies have shown promising results with similar approaches using transcranial magnetic stimulation in various populations, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged 4-10 years old * Meet the diagnostic criteria for ASD of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) * ASD Diagnosis confirmed by the Autism Diagnostic Observation Schedule (ADOS) or Autism Diagnostic Interview, Revised (ADI-R) * IQ of 50 or above * Provide written informed consents Exclusion Criteria: * With metal implants in the body * History of epilepsy or other neurological disease * Require surgical treatment due to structural abnormalities indicated by brain MRI * Diagnosed with genetic and chromosomal abnormalities * With psychiatric/mental disorder (e.g., very early-onset schizophrenia) other than ASD * Suffer from serious heart disease and/or severe hearing impairment * Intracranial hypertension * Participating in other clinical trials * Participants who received other interventions within 4 weeks prior to enrollment.
Where this trial is running
Zhengzhou, Henan and 2 other locations
- Henan Children's Hospital — Zhengzhou, Henan, China (Recruiting)
- Qilu Hospital of Shandong University — Qilu, Shandong, China (Recruiting)
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Fei Li, MD, PhD — Shanghai Jiaotong University School of Medicine Xinhua Hospital
- Study coordinator: Fei Li, MD, PhD
- Email: feili@shsmu.edu.cn
- Phone: +86-18930830950
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.