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Transcranial Pulsed Current Stimulation on Social Functioning and Sleep in Children with Autism Spectrum Disorder: A multi-center, double-blind, sham- controlled, randomized clinical trial

A Multi Center Randomized Controlled Trial for Effect of Transcranial Pulsed Current Stimulation on Social Functionings in Children with Autism Spectrum Disorder

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059118
Enrollment
Unknown
Registered
2022-04-25
Start date
2022-05-02
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Autism Spectrum Disorder (ASD)

Interventions

Intervention group:Active transcranial pulsed current stimulation + Standard therapy (ABA, Structured learning , Play therapy , Speech therapy)
Control group:Sham transcranial pulsed current stimulation + Standard therapy ( ABA, Structured learning , Play therapy , Speech therapy)

Sponsors

Nanhai Maternity and Children's Hospital Affiliated to Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Subject meets the DSM-V(American Psychiatric Association, 2013b) diagnostic criteria for autism spectrum disorder. 2. The subject and parent /legal guardian gave informed consent to the treatment, agree to commit to the course of treatment and complete the various pre- and post-treatment assessments. 3. Children aged 3-14 years, regardless of gender. 4. Subjects with IQ score > 35 , according to WISC (4th edition) 5. No history of epilepsy

Exclusion criteria

Exclusion criteria: 1. Those who do not meet the above inclusion criteria; 2. Subjects 14 years old; 3. Subjects with IQ score < 35, Children with severe cognitive impairment, according to WISC (4th edition) 4. Subjects with comorbid epilepsy or history of epileptic disorders or history of brain tumors or traumatic brain injury; 5. Subjects with presence of congenital genetic metabolic disorders and psychiatric disorders such as schizophrenia and psychosis, or a family history of schizophrenia and psychosis. 6. Subjects diagnosed with obstructive sleep apnea. 7. Subjects with skull defect or presence of severe scalp infection at the proposed site of stimulation. 8. Subjects with a history of craniotomy, presence of any ferromagnetic metal or implanted medical devices in the head or body, eg. cochlear implant, pacemaker or defibrillator; 9. Subjects with history of substance abuse or dependence, use of benzodiazepines, neuroleptics and antipsychotic medications including risperidone and haloperidol; 10. Subjects who have current involvement with other forms of non-invasive brain stimulation including transcranial magnetic stimulation or transcranial direct current stimulation.

Design outcomes

Primary

MeasureTime frame
Autism Treatment Evaluation Checklist;

Secondary

MeasureTime frame
Autism Behaviour Checklist;Children's Sleep Habits Questionnaire;

Countries

China

Contacts

Public ContactLiu Zhenhuan

Nanhai Maternity and Children's Hospital Affiliated to Guangzhou University of Chinese Medicine

lzh1958424@163.com+86 139 2318 5885

Outcome results

None listed

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