Abdominal Transcutaneous Electrical Acupoint Stimulation on Children With Autism Spectrum Disorder: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Childhood Autism Rating Scale (CARS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Interventional Study Model is consisted of ABA therapy combined with TEAS treatment or sham TEAS treatment. The common ABA therapy can be effective for anyone, including any child with ASD. Each specific rehabilitation training method of ABA has its own characteristics: DTT (Discrete TrialTraining) is critical to the establishment of attention, listening to commands and other abilities; VB (Verbal Behavior) is very helpful for language ability; PRT (Pivotal Response Treatment) has an obvious effect on children who are severely affected; NET (Natural Education Training)helps to generalize the content in one-to-one courses. Following randomization, participants had an appointment with the TEAS operator. The Zhongwan (RN 12), bilateral Tianshu (ST 25), Qihai (RN 6) and Guanyuan (RN 4) acupoints were selected according to the concept of traditional Chinese medicine that specialized in treating gastrointestinal diseases, improving intestinal function.
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed as autism based on the DSM-V and Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
- •Aged 3 to 6 years
排除标准
- •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
研究组 & 干预措施
ABA Therapy with active 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 total of 40 sessions.
The ABA therapy focuses on enhancing skills in areas such as social interaction, communication, academics, motor function, and self-care. Each session lasts 30 minutes, conducts once daily, five days per week, for a total of 40 sessions.
干预措施: abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS) (Device)
ABA Therapy with Sham TEAS
The sham 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 0 mA. Each session lasts 30 minutes, conducts once daily, five days per week, for a total of 40 sessions.
ABA therapy focuses on enhancing skills in areas such as social interaction, communication, academics, motor function, and self-care. Each session lasts 30 minutes, conducts once daily, five days per week, for a total of 40 sessions.
干预措施: abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS) (Device)
结局指标
主要结局
Childhood Autism Rating Scale (CARS)
时间窗: From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.
CARS is a 15 item behavioral rating scale developed to identify children with autism and to categorize these behaviors from mild to moderate to severe.
次要结局
- The Clinical Global lmpression - lmprovement scale (CGI-I)(From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.)
- Social Responsiveness Scale-2 (SRS-2)(From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.)
- Autism Treatment Evaluation Checklist (ATEC)(From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.)
- Gastrointestinal Symptom Rating Scale (GSRS)(From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.)
- 6-Item Gastrointestinal Severity Index (6-GSI)(From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.)
- Bristol Stool Scale (BSS)(From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.)
- Differences in gut microbiota composition(From enrollment to the end of treatment at 8 weeks.)