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Transcutaneous Electrical Acupoint Stimulation for the Treatment of ADHD

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ClinicalTrials.gov Identifier: NCT03917953
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
Xian Children's Hospital
Shaanxi Hospital of Traditional Chinese Medicine
Fourth Military Medical University
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Brief Summary:

RATIONALE: Transcutaneous electrical acupoint stimulation may improve attention deficit hyperactivity disorder (ADHD).

PURPOSE: This randomized-controlled trial study of treating attention deficit hyperactivity disorder of school-aged children with transcutaneous electrical acupoint stimulation to see how well it works compared to sham transcutaneous electrical acupoint stimulation.


Condition or disease Intervention/treatment Phase
ADHD Device: Transcutaneous Electrical Acupoint Stimulation Not Applicable

Detailed Description:

OBJECTIVES:

Primary

To determine whether true transcutaneous electrical acupoint stimulation(TEAS) administered twice weekly for 4 weeks (8 sessions) compared to sham TEAS causes a significant improvement in core symptoms of ADHD according to the standard enacted by the national traditional Chinese medicine committee and relapse rate was evaluated after a half-year follow up.

Secondary

To evaluate the diversity of the gut microbiota before and after 4 weeks TEAS treatment.

To evaluate the brain activity using a NIRS system before and after 4 weeks TEAS treatment.

To assess the safety and tolerability of TEAS in this study population.

OUTLINE: This is a multicenter study. Patients are stratified according to study site. Patients are randomized to two treatment arms.

Arm I: Patients receive TEAS twice weekly for 4 weeks . Arm II: Patients receive sham TEAS twice weekly for 4 weeks .

After completion of study treatment, patients are followed up at 24 weeks.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcutaneous Electrical Acupoint Stimulation for Treating Attention Deficit Hyperactivity Disorder: A Prospective, Randomized, Controlled Trial
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I
Patients receive transcutaneous electrical acupoint stimulation therapy twice weekly for 4 weeks.
Device: Transcutaneous Electrical Acupoint Stimulation

Patients in the experimental group will be treated for 20 min TEAS, twice a week, for a total of 4 weeks of treatment.The same intervention was performed in the sham group (electrode patches were attached at corresponding acupointswithout electroacupuncture stimulation).

Acupoint selection: baihui (DU20), taichong (LR3), taixi (KI3).


Sham Comparator: Arm II
Patients receive sham transcutaneous electrical acupoint stimulation therapy twice weekly for 4 weeks.
Device: Transcutaneous Electrical Acupoint Stimulation

Patients in the experimental group will be treated for 20 min TEAS, twice a week, for a total of 4 weeks of treatment.The same intervention was performed in the sham group (electrode patches were attached at corresponding acupointswithout electroacupuncture stimulation).

Acupoint selection: baihui (DU20), taichong (LR3), taixi (KI3).





Primary Outcome Measures :
  1. The efficacy of transcutaneous electrical acupoint stimulation in treating ADHD: Number of active patients/(Number of active patients+Improved patient Numbers+Number of invalid patients)*100% [ Time Frame: 5 weeks ]
    The efficacy(%)=Number of active patients/(Number of active patients+Improved patient Numbers+Number of invalid patients)*100%


Secondary Outcome Measures :
  1. Diversity changes of intestinal flora before and after TEAS treatment [ Time Frame: 5weeks ]
    To identify fecal bacterial taxa and their predicted gene functions by 16S rRNA marker gene sequencing (16S) in ADHD participants.

  2. The higher brain functions change before and after TEAS treatment [ Time Frame: 5 weeks ]
    We monitored the oxy-hemoglobin signal changes of ADHD participants (6-12 years old) performing a go/no-go task by functional nearinfrared spectroscopy (fNIRS).



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be conform to ADHD clinical diagnostic criteria (DSM-V).
  • Patients' ages are between 6~12 years old.
  • An informed written consent from parents and participants

Exclusion Criteria:

  • Patients have a history of illness that concomitant with other mental and neurological disorders.
  • Patients's IQ score are lower than 70.
  • Patients have used antibiotic drugs for the past one month.
  • Patients have had prior transcutaneous electrical acupoint stimulation treatment within the past 12 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917953


Contacts
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Contact: Lixia Zhuo, Master 13720418610 liyanxjtu@xjtu.edu.cn

Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Xian Children's Hospital
Shaanxi Hospital of Traditional Chinese Medicine
Fourth Military Medical University
Investigators
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Principal Investigator: Yan Li, Dr. First Afflicated Hospital Xian Jiaotong University

Publications:
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03917953     History of Changes
Other Study ID Numbers: XJTU1AF-CRF-2018-003
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders