Abdominal Transcutaneous Electrical Acupoint Stimulation on Children With Autism Spectrum Disorder (TEAS/ASD)

Xi'an Jiaotong University

Status: Not yet enrolling

Conditions: Autism Spectrum Disorder; Autism in Children

Treatments: Device: abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06763237

82305315 (Other Grant/Funding Number)

XJTU1AF2024LSYY-352

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups

ABA Therapy with active TEAS

Active Comparator group

Description:

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:

Device: abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)

ABA Therapy with Sham TEAS

Sham Comparator group

Description:

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:

Device: abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)