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ClinicalTrials.gov ID

NCT06763237

Lead Sponsor

First Affiliated Hospital Xi'an Jiaotong UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

42Estimated

Last Update Posted

Jan 8, 2025Actual

Start Date

Jan 10, 2025Estimated

Primary Completion Date

Jan 10, 2026Estimated

Completion Date

Jan 10, 2026Estimated

Official Title

Abdominal Transcutaneous Electrical Acupoint Stimulation on Children With Autism Spectrum Disorder: A Randomized Clinical Trial

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.

• Autism Spectrum Disorder
• Autism in Children

• abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

First Affiliated Hospital Xi'an Jiaotong UniversityOTHER

Collaborators

Xian Children's HospitalOTHER_GOV

zhangjiexach@xjtu.edu.cnChina: +86 029-87692536