Not yet taking people in ChinaNo phase

Electrical acupoint stimulation on the abdomen for children with autism

Tests abdominal electrical acupoint stimulation in children with autism and gastrointestinal symptoms.

Key facts

Who runs it: First Affiliated Hospital Xi'an Jiaotong University
Where: Xi'an and Xi’an, ChinaSee the 2 sites
Trial code: NCT06763237
Registry title: Abdominal Transcutaneous Electrical Acupoint Stimulation on Children With Autism Spectrum Disorder
Status: Not yet recruiting
People taking part: 42 people, planned
Started: 10 Jan 2025
Planned end: 10 Jan 2026
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)
Record updated: 8 January 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 3 to 6 years with autism. It tests a gentle electrical stimulation of the belly (abdominal TEAS) against a sham version without stimulation.

Age: 3 to 6 years
Sex: Boys and girls can both join.
Disease stage: Autism diagnosed by the DSM-V and the ADOS-2 test. The summary mentions children with stomach and gut symptoms.
Earlier treatment: No antibiotics (by mouth or injection), antipsychotic drugs or psychobiotic supplements in the 30 days before screening. No earlier acupuncture, electroacupuncture or TEAS treatment.

Main reasons for not taking part

Other organic diseases, such as severe hearing or vision problems or brain injury
Neurological disease, such as epilepsy or Rett syndrome
Psychiatric disorder, such as schizophrenia or bipolar disorder
Antibiotics in the 30 days before screening
Earlier acupuncture, electroacupuncture or TEAS treatment

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

Being diagnosed as autism based on the DSM-V and Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
Aged 3 to 6 years

Who cannot take part

Oral or injected antibiotics within 30 days before screening
Taking antipsychotic drugs and psychobiotic supplements within 30 days before screening
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)
History of acupuncture, electroacupuncture, TEAS treatment before screening

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 3 and 6 years old?

Where in China

Xi'an Children's HospitalXi'an, ChinaContact: Jie Zhang, MDNo longer taking part
The First Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaContact: Lixia Zhuo, PhDNo longer taking part

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The 2 groups in the trial

ABA Therapy with active TEASExisting treatment, for comparison
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.
Treatment: abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)
ABA Therapy with Sham TEASSham treatment, for comparison
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.
Treatment: abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)