Clinical trial NCT06763237: Abdominal Transcutaneous Electrical Acupoint Stimulation on Children With Autism Spectrum Disorder
Official title: Abdominal Transcutaneous Electrical Acupoint Stimulation on Children With Autism Spectrum Disorder: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Autism in Children
Keywords: Transcutaneous electrical acupoint stimulation
Gastrointestinal symptoms
Children
Autism spectrum disorder
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Xian Children's Hospital
First posted: 2025-01-08
Enrollment: 42
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS) works to treat autism spectrum disorder (ASD) in children. It will also learn about the safety of abdominal TEAS. The main questions it aims to answer are:

Does abdominal TEAS a safe and effective treatment for children with autism spectrum disorder and gastrointestinal symptoms? Researchers will compare abdominal TEAS to a placebo (a sham abdominal TEAS without stimulation) to see if abdominal TEAS works to treat ASD.

Participants will:

Take abdominal TEAS or sham abdominal TEAS 5 days a week for 8 weeks. Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms.

Detailed description: Following randomization, participants had an appointment with the TEAS operator. The TEAS operators had a minimum of 2 years of experience in acupuncture treatment and held a membership with a national professional association in China. The Zhongwan (RN 12), bilateral Tianshu (ST 25), Qihai (RN 6) and Guanyuan (RN 4) acupuncture points were selected according to the concept of traditional Chinese medicine that specialized in treating gastrointestinal diseases, improving intestinal function, and eliminating various symptoms caused by intestinal dysfunction.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed as autism based on the DSM-V and Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
* Aged 3 to 6 years

Exclusion Criteria:

* Diagnosed with other organic diseases (such as severe hearing and visual impairment, brain trauma) and neurological disease (e.g., epilepsy, Rett syndrome), or psychiatric disorder (schizophrenia, bipolar affective disorder, etc)
* Oral or injected antibiotics within 30 days before screening
* History of acupuncture, electroacupuncture, TEAS treatment before screening
* Taking antipsychotic drugs and psychobiotic supplements within 30 days before screening

Primary outcomes:
measure: Childhood Autism Rating Scale (CARS)
timeFrame: From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.
Secondary outcomes:
measure: The Clinical Global lmpression - lmprovement scale (CGI-I)
timeFrame: From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.
measure: Social Responsiveness Scale-2 (SRS-2)
timeFrame: From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.
measure: Autism Treatment Evaluation Checklist (ATEC)
timeFrame: From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.
measure: 6-Item Gastrointestinal Severity Index (6-GSI)
timeFrame: From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.
measure: Bristol Stool Scale (BSS)
timeFrame: From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.
measure: Differences in gut microbiota composition
timeFrame: From enrollment to the end of treatment at 8 weeks.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The first affiliated hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an Children's Hospital
state: Shaanxi
Study officials:
References:
citation: Zhuo L, Zhao X, Zhai Y, Zhao B, Tian L, Zhang Y, Wang X, Zhang T, Gan X, Yang C, Wang W, Gao W, Wang Q, Rohde LA, Zhang J, Li Y. Transcutaneous electrical acupoint stimulation for children with attention-deficit/hyperactivity disorder: a randomized clinical trial. Transl Psychiatry. 2022 Apr 21;12(1):165. doi: 10.1038/s41398-022-01914-0.
citation: Adams JB, Johansen LJ, Powell LD, Quig D, Rubin RA. Gastrointestinal flora and gastrointestinal status in children with autism--comparisons to typical children and correlation with autism severity. BMC Gastroenterol. 2011 Mar 16;11:22. doi: 10.1186/1471-230X-11-22.
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citation: Dai Y, Zhang L, Yu J, Zhou X, He H, Ji Y, Wang K, Du X, Liu X, Tang Y, Deng S, Langley C, Li WG, Zhang J, Feng J, Sahakian BJ, Luo Q, Li F. Improved symptoms following bumetanide treatment in children aged 3-6 years with autism spectrum disorder: a randomized, double-blind, placebo-controlled trial. Sci Bull (Beijing). 2021 Aug 15;66(15):1591-1598. doi: 10.1016/j.scib.2021.01.008. Epub 2021 Jan 16.
citation: Hirota T, King BH. Autism Spectrum Disorder: A Review. JAMA. 2023 Jan 10;329(2):157-168. doi: 10.1001/jama.2022.23661.