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Autism Spectrum DisorderTEAS/ASDNCT06763237

Abdominal Transcutaneous Electrical Acupoint Stimulation on Children With Autism Spectrum Disorder

A study testing abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS) in people with Autism Spectrum Disorder and Autism in Children, run by First Affiliated Hospital Xi'an Jiaotong University at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 6 years
Conditions the study is for
Autism Spectrum Disorder, Autism in Children
What is being tested?
abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
2 sitesChina
Study dates
10 Jan 2025to 10 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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 join

  • 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 locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lixia Zhuo, PhD contact

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

1829286650@163.com

Yan Li, PhD contact

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

liyanxjtu@xjtu.edu.cn

China2 sites

  • The first affiliated hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Lixia Zhuo, PhD, China: +86 029-85324424 ext. +8618292866500, 18292866500@163.com

    Yan Li, PhD

  • Xi'an Children's Hospital

    Xi'an, Shaanxi, 710069

    Jie Zhang, MD, China: +86 029-87692536, zhangjiexach@xjtu.edu.cn

    Jie Zhang, MD

Other trials in China

About this study

Official title: Abdominal Transcutaneous Electrical Acupoint Stimulation on Children With Autism Spectrum Disorder: A Randomized Clinical Trial

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.

Read more

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.

Read the 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.

Being tested
abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)
Keywords
Transcutaneous electrical acupoint stimulation, Gastrointestinal symptoms, Children, Autism spectrum disorder
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)Device

    Also called TEAS, Applied Behavior Analysis (ABA) therapy

    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.

Study groups in NCT06763237
Study groupRoleWhat they receive
ABA Therapy with active TEASActive comparatorThe 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.
Receives: Device: abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)
ABA Therapy with Sham TEASSham comparatorThe 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.
Receives: Device: abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

  1. The Clinical Global lmpression - lmprovement scale (CGI-I)

    The Clinical Global Impression Scale (CGI) is a 7-point scale that has been adapted so that clinicians can easily and quickly rate social communication behaviors.

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

  2. Social Responsiveness Scale-2 (SRS-2)

    The Social Responsiveness Scale-2 (SRS-2) measures the presence and severity of social impairments within the autism spectrum. Parents, teachers, or other observers evaluate social abilities in various natural settings for children between 2.5 and 18 years using age-appropriate forms with 65 Likert-scale items. SRS-2 has 5 subscales: social awareness, social cognition, social communication, social motivation, restricted interests, and repetitive behavior. The total continuous score indicates the severity of social deficits in the autism spectrum.

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

  3. Autism Treatment Evaluation Checklist (ATEC)

    The Autism Treatment Evaluation Checklist (ATEC) is a method to assess how an individual with autism is progressing over time. It was developed with the aim of evaluating a wide array of behaviors and skills, thereby offering a comprehensive look at an individual's abilities and challenges. This makes it a valuable tool for tracking the effectiveness of various autism treatments. It is designed to be filled out by individuals who know the person with autism well, such as parents or primary caregivers, and can be completed in approximately 10-20 minutes. The ATEC spans four subtests: Speech/Language/Communication、Sociability、Sensory/Cognitive Awareness、Health/Physical/Behavior. These subtests evaluate various aspects, including verbal and non-verbal communication skills, social interactions, sensory responses, cognitive abilities, physical health, and behaviors.

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

  4. Gastrointestinal Symptom Rating Scale (GSRS)

    The GSRS is self-administered scale and has 15 questions divided into 5 domains that cover the gastrointestinal system: diarrhea, constipation, abdominal pain, reflux and indigestion. The scale answers are arranged according to the 4-point Likert scale, in which "1" indicates absence and "4" the higher frequency or intensity of the symptoms. This tool has already been validated as to their questions and assessment scales (construct validity and criterion validity).

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

  5. 6-Item Gastrointestinal Severity Index (6-GSI)

    The severity of GI symptoms was assessed using a shortened version of the 6-item Gastrointestinal Severity Index (6-GSI) questionnaire, composed of six symptoms, including constipation, diarrhea, stool consistency, stool smell, flatulence, and abdominal pain. Each symptom is rated on a three-point Likert-type scale ranging from 0 to 2, with a higher score signifying more severe GI symptoms.

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

  6. Bristol Stool Scale (BSS)

    The Bristol Stool Scale (BSS) is a 7-point scale used extensively in clinical practice and research for stool form measurement. This is a tool to assist patients, family members and health care providers to share common language about stool consistency. The original Bristol Stool Form Scale description with notations in brackets: Type 1 Separate hard lumps, like nuts [constipation/encopresis, difficult to pass] Type 2 Sausage-shaped but lumpy Type 3 Like a sausage or snake but with cracks on its surface Type 4 Like a sausage or snake, smooth and soft [average stool] Type 5 Soft blobs with clear-cut edges Type 6 Fluffy pieces with ragged edges, a mushy stool Type 7 Watery, no solid pieces. [diarrhea, easy to pass and may involuntarily be passed]

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

  7. Differences in gut microbiota composition

    Differences in gut microbiota composition in children with ASD before and after intervention. It involves studying the collective genomes of microorganisms that reside in the gastrointestinal tract. This approach aims to understand the composition, diversity, and functional potential of the microbiota, which plays a crucial role in human health and well-being. By analyzing the DNA extracted directly from fecal samples, researchers can identify and characterize the various bacterial, viral, and fungal species present in the gut.

    Measured: From enrollment to the end of treatment at 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2025
  2. Study start10 Jan 2025 (estimated)
  3. Primary completion10 Jan 2026 (estimated)
  4. Study completion10 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06763237
Sponsor's protocol ID
XJTU1AF2024LSYY-352
Other IDs
82305315
Acronym
TEAS/ASD
Status last verified
Jan 2025
First submitted
18 Nov 2024
Last updated
8 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Baseline characteristics of patients, the primary and secondary outcomes.

Publications

  • 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.

    PubMed 35449191

  • 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.

    PubMed 21410934

  • 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.

    PubMed 34800004

  • 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.

    PubMed 34198499

  • 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.

    PubMed 36654288

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

    PubMed 36625807

Questions about this trial

What is this clinical trial studying?

A study testing abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS) in people with Autism Spectrum Disorder and Autism in Children, run by First Affiliated Hospital Xi'an Jiaotong University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lixia Zhuo, PhD (China: +86 029-85324424 ext. +86 1829286650, 1829286650@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Childhood Autism Rating Scale (CARS) (time frame: From enrollment to the end of treatment at 8 weeks, and follow up to 16 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06763237, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.

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