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.
Being diagnosed as autism based on the DSM-V and Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
Aged 3 to 6 years
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
Parallel
abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)
DeviceThe 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. ABA is delivered in a variety of settings, including school, home, clinic, and other community settings. The goal of treatment is to help children function as independently and successfully as possible. Each session lasts 30 minutes, conducts once daily, five days per week, for a total of 40 sessions.
Childhood Autism Rating Scale (CARS)
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.
The Clinical Global lmpression - lmprovement scale (CGI-I)
The Clinical Global Impression Scale (CGI) is a 7-point scale that has been adapted so that clinicians can easily and quickly rate social communication behaviors.
Social Responsiveness Scale-2 (SRS-2)
The Social Responsiveness Scale-2 (SRS-2) measures the presence and severity of social impairments within the autism spectrum. Parents, teachers, or other observers evaluate social abilities in various natural settings for children between 2.5 and 18 years using age-appropriate forms with 65 Likert-scale items. SRS-2 has 5 subscales: social awareness, social cognition, social communication, social motivation, restricted interests, and repetitive behavior. The total continuous score indicates the severity of social deficits in the autism spectrum.
Autism Treatment Evaluation Checklist (ATEC)
The Autism Treatment Evaluation Checklist (ATEC) is a method to assess how an individual with autism is progressing over time. It was developed with the aim of evaluating a wide array of behaviors and skills, thereby offering a comprehensive look at an individual's abilities and challenges. This makes it a valuable tool for tracking the effectiveness of various autism treatments. It is designed to be filled out by individuals who know the person with autism well, such as parents or primary caregivers, and can be completed in approximately 10-20 minutes. The ATEC spans four subtests: Speech/Language/Communication、Sociability、Sensory/Cognitive Awareness、Health/Physical/Behavior. These subtests evaluate various aspects, including verbal and non-verbal communication skills, social interactions, sensory responses, cognitive abilities, physical health, and behaviors.
Gastrointestinal Symptom Rating Scale (GSRS)
The GSRS is self-administered scale and has 15 questions divided into 5 domains that cover the gastrointestinal system: diarrhea, constipation, abdominal pain, reflux and indigestion. The scale answers are arranged according to the 4-point Likert scale, in which "1" indicates absence and "4" the higher frequency or intensity of the symptoms. This tool has already been validated as to their questions and assessment scales (construct validity and criterion validity).
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First Affiliated Hospital Xi'an Jiaotong University
Lead sponsor
Xian Children's Hospital
Collaborator
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