Abdominal Transcutaneous Electrical Acupoint Stimulation on Children With Autism Spectrum Disorder

NCT ID: NCT06763237

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2026-01-10

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.

Conditions

Autism Spectrum Disorder; Autism in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ABA Therapy with active 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. Each session lasts 30 minutes, conducts once daily, five days per week, for a total of 40 sessions.

Group Type: ACTIVE_COMPARATOR

abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)

Intervention Type: DEVICE

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.

ABA Therapy with Sham TEAS

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.

Group Type: SHAM_COMPARATOR

abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

TEAS; Applied Behavior Analysis (ABA) therapy

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xian Children's Hospital

OTHER_GOV

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The first affiliated hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Xi'an Children's Hospital

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Lixia Zhuo, PhD

Role: CONTACT

1829286650@163.com

China: +86 029-85324424 ext. +86 1829286650

Yan Li, PhD

Role: CONTACT

liyanxjtu@xjtu.edu.cn

China: +86 029-85323539 ext. +86 1372041861

Facility Contacts

Lixia Zhuo, PhD

Role: primary

18292866500@163.com

China: +86 029-85324424 ext. +8618292866500

Jie Zhang, MD

Role: primary

zhangjiexach@xjtu.edu.cn

China: +86 029-87692536

References

Zhuo L, Zhao X, Zhai Y, Zhao B, Tian L, Zhang Y, Wang X, Zhang T, Gan X, Yang C, Wang W, Gao W, Wang Q, Rohde LA, Zhang J, Li Y. Transcutaneous electrical acupoint stimulation for children with attention-deficit/hyperactivity disorder: a randomized clinical trial. Transl Psychiatry. 2022 Apr 21;12(1):165. doi: 10.1038/s41398-022-01914-0.

Reference Type: RESULT

PMID: 35449191 (View on PubMed)

Adams JB, Johansen LJ, Powell LD, Quig D, Rubin RA. Gastrointestinal flora and gastrointestinal status in children with autism--comparisons to typical children and correlation with autism severity. BMC Gastroenterol. 2011 Mar 16;11:22. doi: 10.1186/1471-230X-11-22.

Reference Type: RESULT

PMID: 21410934 (View on PubMed)

Toolan C, Holbrook A, Schlink A, Shire S, Brady N, Kasari C. Using the Clinical Global Impression scale to assess social communication change in minimally verbal children with autism spectrum disorder. Autism Res. 2022 Feb;15(2):284-295. doi: 10.1002/aur.2638. Epub 2021 Nov 19.

Reference Type: RESULT

PMID: 34800004 (View on PubMed)

Mensi MM, Rogantini C, Marchesi M, Borgatti R, Chiappedi M. Lactobacillus plantarum PS128 and Other Probiotics in Children and Adolescents with Autism Spectrum Disorder: A Real-World Experience. Nutrients. 2021 Jun 14;13(6):2036. doi: 10.3390/nu13062036.

Reference Type: RESULT

PMID: 34198499 (View on PubMed)

Dai Y, Zhang L, Yu J, Zhou X, He H, Ji Y, Wang K, Du X, Liu X, Tang Y, Deng S, Langley C, Li WG, Zhang J, Feng J, Sahakian BJ, Luo Q, Li F. Improved symptoms following bumetanide treatment in children aged 3-6 years with autism spectrum disorder: a randomized, double-blind, placebo-controlled trial. Sci Bull (Beijing). 2021 Aug 15;66(15):1591-1598. doi: 10.1016/j.scib.2021.01.008. Epub 2021 Jan 16.

Reference Type: RESULT

PMID: 36654288 (View on PubMed)

Hirota T, King BH. Autism Spectrum Disorder: A Review. JAMA. 2023 Jan 10;329(2):157-168. doi: 10.1001/jama.2022.23661.

Reference Type: RESULT

PMID: 36625807 (View on PubMed)

Related Links

https://www.medicalresearch.org.cn/clinicalResearch/researchInfo?id=67587e4d-2bf5-4cda-88c2-cf10fea5b21a

Related Info

Other Identifiers

82305315

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

XJTU1AF2024LSYY-352

Identifier Type: -

Identifier Source: org_study_id