NCT06763237

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

November 18, 2024

Last Update Submit

January 2, 2025

Conditions

Autism Spectrum DisorderAutism in Children

Keywords

Transcutaneous electrical acupoint stimulationGastrointestinal symptomsChildrenAutism spectrum disorder

Outcome Measures

Primary Outcomes (1)

  • Childhood Autism Rating Scale (CARS)

    CARS is a 15 item behavioral rating scale developed to identify children with autism and to categorize these behaviors from mild to moderate to severe.

    From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.

Secondary Outcomes (7)

  • The Clinical Global lmpression - lmprovement scale (CGI-I)

    From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.

  • Social Responsiveness Scale-2 (SRS-2)

    From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.

  • Autism Treatment Evaluation Checklist (ATEC)

    From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.

  • Gastrointestinal Symptom Rating Scale (GSRS)

    From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.

  • 6-Item Gastrointestinal Severity Index (6-GSI)

    From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.

  • +2 more secondary outcomes

Study Arms (2)

ABA Therapy with active TEAS

ACTIVE COMPARATOR

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.

Device: abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)

ABA Therapy with Sham TEAS

SHAM COMPARATOR

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.

Device: abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)

Interventions

abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)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.

Also known as: TEAS, Applied Behavior Analysis (ABA) therapy
ABA Therapy with Sham TEASABA Therapy with active TEAS

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The first affiliated hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Xi'an Children's Hospital

Xi'an, Shaanxi, 710069, China

Location

Related Publications (6)

  • 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.

    PMID: 35449191RESULT

  • 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.

    PMID: 21410934RESULT

  • 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.

    PMID: 34800004RESULT

  • 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.

    PMID: 34198499RESULT

  • 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.

    PMID: 36654288RESULT

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

    PMID: 36625807RESULT

Related Links

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Lixia Zhuo, PhD

CONTACT

China: +86 029-853244241829286650@163.com

Yan Li, PhD

CONTACT

China: +86 029-85323539liyanxjtu@xjtu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Interventional Study Model is consisted of ABA therapy combined with TEAS treatment or sham TEAS treatment. The common ABA therapy can be effective for anyone, including any child with ASD. Each specific rehabilitation training method of ABA has its own characteristics: DTT (Discrete TrialTraining) is critical to the establishment of attention, listening to commands and other abilities; VB (Verbal Behavior) is very helpful for language ability; PRT (Pivotal Response Treatment) has an obvious effect on children who are severely affected; NET (Natural Education Training)helps to generalize the content in one-to-one courses. Following randomization, participants had an appointment with the TEAS operator. The Zhongwan (RN 12), bilateral Tianshu (ST 25), Qihai (RN 6) and Guanyuan (RN 4) acupoints were selected according to the concept of traditional Chinese medicine that specialized in treating gastrointestinal diseases, improving intestinal function.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2024

First Posted

January 8, 2025

Study Start

January 10, 2025

Primary Completion

January 10, 2026

Study Completion

January 10, 2026

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Baseline characteristics of patients, the primary and secondary outcomes.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Ending 2 years after the publication of results.
Access Criteria
The IPD is available for sharing with qualified researchers or organizations upon request. The researchers must meet to be eligible for accessing IPD, such as having a scientifically sound research proposal, being affiliated with an academic institution or research organization, and having appropriate ethical approval. Researchers must agree to a data use agreement that outlines the terms and conditions of using the shared IPD, including confidentiality, data security, and intellectual property rights. The registry should submit a research proposal, reviewing the proposal by an independent committee, and granting access once the proposal is approved. The shared IPD is protected from unauthorized access, use, or disclosure, and that appropriate measures are in place to maintain participant confidentiality and privacy. The researchers can access IPD by contact the principle investigator of this study.

Locations

CN(2)