Improving social function in children with autism using brain stimulation
The Validation and Biological Index Studies on the Improved Social Function of Autism Spectrum Disorder by 40 Hz Transcranial Alternating Current Stimulation
NA · Central South University · NCT06362200
This study tests if a brain stimulation technique can help improve social skills in children and teens with autism.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Central South University (other) |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06362200 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the effects of transcranial alternating current stimulation (tACS) on children and adolescents diagnosed with autism spectrum disorder (ASD). Participants aged 6-18 will undergo a series of assessments, including EEG and MRI, to evaluate brain activity and connectivity. They will be randomly assigned to receive either active tACS at 40 Hz or a sham stimulation, allowing researchers to compare the efficacy of the treatment. The study aims to understand the internal mechanisms of ASD and how tACS may improve social functioning.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6-18 who have been clinically diagnosed with autism spectrum disorder.
Not a fit: Patients with serious neurological disorders, genetic disorders, or significant physical diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance social functioning in children and adolescents with autism spectrum disorder.
How similar studies have performed: While the use of tACS in treating ASD is a novel approach, similar studies have shown promise in other neurological conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 6-18 years old. 2. has been clinically diagnosed with autism spectrum disorder by a psychiatrist 3. Meet the diagnostic criteria for ASD recommended by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 4. Consistent with the diagnosis of ASD by used the Autism Diagnostic Interview Tool - Revised Edition (ADI-R) and the Autism Diagnostic Observation Tool (ADOS) assessment. 5. Can cooperate with transcranial alternating current stimulation. Exclusion Criteria: b) There is a serious neurological disorder, a clear family history or a potential risk. c) There are metal implants in the brain, holes or cracks in the skull. e) The presence of a definite or suspected genetic disorder. 1. the presence of common genetic disorders, such as trisomy 21 syndrome 2. The presence of serious physical diseases, such as significant intracranial lesions, thyroid disease, epilepsy, congenital heart disease, severe blood system diseases, systemic lupus erythematosus, audio-visual impairment, etc. 3. meet the diagnosis of other major mental disorders, such as schizophrenia and bipolar disorder. 4. Imaging examination reveals obvious abnormalities in brain structure. 5. Currently taking or have taken benzodiazepine medications or antiepileptic drugs within the past week.
Where this trial is running
Changsha, Hunan
- Department of Psychiatry, Xiangya Second Hospital, Central South University — Changsha, Hunan, China (RECRUITING)
Study contacts
- Study coordinator: Jianjun Ou, doctor
- Email: oujianjun@csu.edu.cn
- Phone: 17775861486
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 Disorder