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Abdominal Transcutaneous Electrical Acupoint Stimulation on Children With Autism Spectrum Disorder

NCT06763237 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-01-08

No results posted yet for this study

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.

Conditions

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 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.

Sponsors & Collaborators

  • Xian Children's Hospital

    collaborator OTHER_GOV

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-10
Primary Completion
2026-01-10
Completion
2026-01-10

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06763237 on ClinicalTrials.gov