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

Overview

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.

Interventions

• Device abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)
  The TEAS intervention is delivered using an electroacupuncture device (SDZ-V, Hwato, Soochow Medical Instruments Co., Ltd., China). Self-adhesive electrodes are placed at acupoints Zhongwan (RN12), bilateral Tianshu (ST25), Qihai (RN6), and Guanyuan (RN4). Stimulation is applied using dense-sparse wave alternating frequencies (3 Hz for 2 s cycles) at an intensity of 3-10 mA, adjusted to the participant's tolerance. Each session lasts 30 minutes, conducts once daily, five days per week, for a tot

Primary outcome measures

• Childhood Autism Rating Scale (CARS) [Time frame: From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.]

Secondary outcome measures (7)

• The Clinical Global lmpression - lmprovement scale (CGI-I) [Time frame: From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.]
• Social Responsiveness Scale-2 (SRS-2) [Time frame: From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.]
• Autism Treatment Evaluation Checklist (ATEC) [Time frame: From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.]
• Gastrointestinal Symptom Rating Scale (GSRS) [Time frame: From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.]
• 6-Item Gastrointestinal Severity Index (6-GSI) [Time frame: From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.]
• Bristol Stool Scale (BSS) [Time frame: From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.]
• Differences in gut microbiota composition [Time frame: From enrollment to the end of treatment at 8 weeks.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 2 centers

• The first affiliated hospital of Xi'an Jiaotong University — Xi'an
• Xi'an Children's Hospital — Xi'an

Publications

• 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. PMID 35449191
• 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. PMID 21410934
• Toolan C, Holbrook A, Schlink A, Shire S, Brady N, Kasari C. Using the Clinical Global Impression scale to assess social communication change in minimally verbal children with autism spectrum disorder. Autism Res. 2022 Feb;15(2):284-295. doi: 10.1002/aur.2638. Epub 2021 Nov 19. PMID 34800004
• Mensi MM, Rogantini C, Marchesi M, Borgatti R, Chiappedi M. Lactobacillus plantarum PS128 and Other Probiotics in Children and Adolescents with Autism Spectrum Disorder: A Real-World Experience. Nutrients. 2021 Jun 14;13(6):2036. doi: 10.3390/nu13062036. PMID 34198499
• 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 PMID 36654288
• Hirota T, King BH. Autism Spectrum Disorder: A Review. JAMA. 2023 Jan 10;329(2):157-168. doi: 10.1001/jama.2022.23661. PMID 36625807

Identifiers

NCT: NCT06763237 · XJTU1AF2024LSYY-352 · 82305315

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗