Transcutaneous Electrical Acupoint Stimulation for the Treatment of ADHD
NCT ID: NCT03917953
Last Updated: 2021-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
78 participants
INTERVENTIONAL
2019-07-01
2020-01-17
Brief Summary
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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.
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Detailed Description
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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 symptoms of ADHD according to the investigator-rated Clinical Global Impression-Improvement (CGI-I) scores at week 4.
Secondary
To evaluate the changes from baseline to week 4 of Clinical Global Impressions Scale-Severity of Illness (CGI-S)，Conners'Parent Rating Scales-Revised: Short Form (CPRS-R: S) score, Conners'Teacher Rating Scales-Revised: Short Form (CTRS-R: S) score, go/no-go task performances, and the concentration of oxygenated hemoglobin within the prefrontal cortex.
OUTLINE: This is a single-center study. 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 .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm I
Patients receive transcutaneous electrical acupoint stimulation therapy twice weekly for 4 weeks.
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 acupoints without electrical stimulation).
Acupoint selection: baihui (GV 20), taichong (LR 3), taixi (KI 3).
Arm II
Patients receive sham transcutaneous electrical acupoint stimulation therapy twice weekly for 4 weeks.
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 acupoints without electrical stimulation).
Acupoint selection: baihui (GV 20), taichong (LR 3), taixi (KI 3).
Interventions
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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 acupoints without electrical stimulation).
Acupoint selection: baihui (GV 20), taichong (LR 3), taixi (KI 3).
Eligibility Criteria
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Inclusion Criteria
* Patients' ages are between 6\~12 years old.
* An informed written consent from parents and participants
Exclusion Criteria
* Patients's IQ score are lower than 75.
* Patients have had prior TEAS or other acupoints-associated treatment experiences.
* Left handedness.
6 Years
12 Years
ALL
No
Sponsors
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Xian Children's Hospital
OTHER_GOV
Shaanxi Hospital of Traditional Chinese Medicine
OTHER
Air Force Military Medical University, China
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Responsible Party
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Principal Investigators
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Yan Li, Dr.
Role: PRINCIPAL_INVESTIGATOR
First Afflicated Hospital Xian Jiaotong University
Locations
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Xian Children's Hospital
Xi'an, Shaanxi, China
Countries
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References
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Thapar A, Cooper M. Attention deficit hyperactivity disorder. Lancet. 2016 Mar 19;387(10024):1240-50. doi: 10.1016/S0140-6736(15)00238-X. Epub 2015 Sep 17.
Lee MS, Choi TY, Kim JI, Kim L, Ernst E. Acupuncture for treating attention deficit hyperactivity disorder: a systematic review and meta-analysis. Chin J Integr Med. 2011 Apr;17(4):257-60. doi: 10.1007/s11655-011-0701-7. Epub 2011 Apr 21.
Liu Z, Liu Y, Xu H, He L, Chen Y, Fu L, Li N, Lu Y, Su T, Sun J, Wang J, Yue Z, Zhang W, Zhao J, Zhou Z, Wu J, Zhou K, Ai Y, Zhou J, Pang R, Wang Y, Qin Z, Yan S, Li H, Luo L, Liu B. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2493-2501. doi: 10.1001/jama.2017.7220.
Liu Z, Yan S, Wu J, He L, Li N, Dong G, Fang J, Fu W, Fu L, Sun J, Wang L, Wang S, Yang J, Zhang H, Zhang J, Zhao J, Zhou W, Zhou Z, Ai Y, Zhou K, Liu J, Xu H, Cai Y, Liu B. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med. 2016 Dec 6;165(11):761-769. doi: 10.7326/M15-3118. Epub 2016 Sep 13.
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.
Other Identifiers
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XJTU1AF-CRF-2018-003
Identifier Type: -
Identifier Source: org_study_id
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