Feasibility, safety and efficacy of high-dose intermittent theta burst stimulation in children with autism spectrum disorder

Study on the efficacy and mechanism of intermittent theta burst stimulation in the treatment of autism spectrum disorder

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400089757

Enrollment

Unknown

Registered

2024-09-14

Start date

2024-10-01

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism spectrum disorder

Interventions

iTBS group:The left dorsomedial prefrontal cortex was stimulated using intermittent theta burst stimulation

sham group:Patients can hear the sound produced during TMS intervention with a sham stimulation, but the magnetic field of the target is close to 0, the cerebral cortex is not affected by the pulsed m

Eligibility

Sex/Gender

All

Age

2 Years to 10 Years

Inclusion criteria

Inclusion criteria: ? Meet the diagnostic criteria for autism in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, published by the American Psychiatric Association, with a clear diagnosis issued by a hospital of the third grade or above; ? Age 2-10 years old, regardless of gender.?The guardian of the subject gave informed consent and signed informed consent, and accompanied the autistic child throughout the intervention process.

Exclusion criteria

Exclusion criteria: ? current or previous comorbid psychotic disorders, including schizophrenia, schizoaffective disorder, bipolar disorder, etc.; ? serious self-injury or suicidal behaviour in the last year category; ? serious visual, auditory, deafness, or movement disorders can not cooperate with the examination and treatment of the person; ? epilepsy and epilepsy in patients with a history of family history of epilepsy; ? suffering from serious organic lesions, such as congenital heart disease, craniocerebral injury, intracranial pressure Patients with severe organic lesions, such as congenital heart disease, craniocerebral injury, intracranial pressure; ? Patients who have received neuromodulation therapy such as transcranial magnetic stimulation, transcranial direct current stimulation, transcranial focused ultrasound, etc., in the 3 months prior to enrollment; ? Patients with intracranial metallic implants; ? Patients who are undergoing other clinical trials; and ? Patients or their family members do not agree to undergo the treatment/inspection.

Design outcomes

Primary

Measure	Time frame
Autism Behavior Checklist,ABC;Social Response Scale, second edition,SRS-2;Childhood Autism Rating Scale,CARS;	—

Secondary

Measure	Time frame
Autism Treatment Evaluation Checklist,ATEC;Repeated Behavior Scale-Revision,RBS-R;Functional Near Infrared Spectroscopy;electroencephalography;Salivary levels of oxytocin, growth hormone, IGF-1 and IGFBP-3;	—

Countries

China

Contacts

Public ContactHao Zhang

China Rehabilitation Research Center

crrczh2020@163.com+86 137 0135 6685

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026