Abdominal Transcutaneous Electrical Acupoint Stimulation on Children With Autism Spectrum Disorder

Not Applicable

Not yet recruiting

• Conditions: Autism Spectrum Disorder; Autism in Children

• Registration Number: NCT06763237
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Timeline

• Study First Submitted: 2024-11-18
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Study Start: 2025-01-10
• Primary Completion: 2026-01-10
• Study Completion: 2026-01-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Childhood Autism Rating Scale (CARS)	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.

Secondary Outcome Measures

Name	Time	Method
The Clinical Global lmpression - lmprovement scale (CGI-I)	From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.	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)	From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.	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)	From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.	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)	From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.	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).
6-Item Gastrointestinal Severity Index (6-GSI)	From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.	The severity of GI symptoms was assessed using a shortened version of the 6-item Gastrointestinal Severity Index (6-GSI) questionnaire, composed of six symptoms, including constipation, diarrhea, stool consistency, stool smell, flatulence, and abdominal pain. Each symptom is rated on a three-point Likert-type scale ranging from 0 to 2, with a higher score signifying more severe GI symptoms.
Bristol Stool Scale (BSS)	From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.	The Bristol Stool Scale (BSS) is a 7-point scale used extensively in clinical practice and research for stool form measurement. This is a tool to assist patients, family members and health care providers to share common language about stool consistency. The original Bristol Stool Form Scale description with notations in brackets: Type 1 Separate hard lumps, like nuts \[constipation/encopresis, difficult to pass\] Type 2 Sausage-shaped but lumpy Type 3 Like a sausage or snake but with cracks on its surface Type 4 Like a sausage or snake, smooth and soft \[average stool\] Type 5 Soft blobs with clear-cut edges Type 6 Fluffy pieces with ragged edges, a mushy stool Type 7 Watery, no solid pieces. \[diarrhea, easy to pass and may involuntarily be passed\]
Differences in gut microbiota composition	From enrollment to the end of treatment at 8 weeks.	Differences in gut microbiota composition in children with ASD before and after intervention. It involves studying the collective genomes of microorganisms that reside in the gastrointestinal tract. This approach aims to understand the composition, diversity, and functional potential of the microbiota, which plays a crucial role in human health and well-being. By analyzing the DNA extracted directly from fecal samples, researchers can identify and characterize the various bacterial, viral, and fungal species present in the gut.

Trial Locations

Locations (2)

The first affiliated hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

Xi'an Children's Hospital; 🇨🇳 Xi'an, Shaanxi, China