Transcutaneous Electrical Acupoint Stimulation for the Treatment of ADHD

ADHD Clinical Trial

Official title:

Transcutaneous Electrical Acupoint Stimulation for Treating Attention Deficit Hyperactivity Disorder: A Prospective, Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03917953
• Other study ID #: XJTU1AF-CRF-2018-003
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: January 17, 2020

Study information

• Verified date: February 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 17, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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 75.

• Patients have had prior TEAS or other acupoints-associated treatment experiences.

• Left handedness.

Related Conditions & MeSH terms

• ADHD

Intervention

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 acupoints without electrical stimulation). Acupoint selection: baihui (GV 20), taichong (LR 3), taixi (KI 3).

Locations

Country	Name	City	State
China	Xian Children's Hospital	Xi'an	Shaanxi

Sponsors (4)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Air Force Military Medical University, China, Shaanxi Hospital of Traditional Chinese Medicine, Xian Children's Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the investigator-rated Clinical Global Impression-Improvement (CGI-I) scores	The CGI-Improvement scale was used to evaluate the improvement, maintenance, or worsening of subjects' symptoms compared to baseline. The CGI-Improvement Scale includes seven options for scoring: 1 very much improved; 2 much improved; 3 minimally improved; 4 no change; 5 minimally worse; 6 much worse; and 7 very much worse. Clinical response at week 4 was defined as a rating of "much" or "very much improved" (1 or 2), which is considered a clinically meaningful response.	4 weeks
Secondary	Clinical Global Impression-Improvement-Severity (CGI-S) score	The CGI-S includes seven options for scoring: 1 normal, not at all ill; 2 borderline mentally ill; 3 mildly ill; 4 moderately ill; 5 markedly ill; 6 severely ill; and 7 among the most extremely ill patients.	4 weeks
Secondary	Conners' Parent Rating Scales-Revised: Short Form (CPRS-R: S) score	The CTRS-R:S is a teacher-rated 27-item 4-point Likert rating scale that contains items on ADHD and comorbid conditions (i.e., problems with conduct, emotion, anger control, and anxiety) in the home setting.	4 weeks
Secondary	Conners' Teacher Rating Scales-Revised: Short Form (CTRS-R: S) score	The CTRS-R:S is a teacher-rated 28-item 4-point Likert rating scale that contains items on ADHD and comorbid conditions (i.e., problems with conduct, emotion, anger control, and anxiety) in the school setting.	4 weeks
Secondary	go/no-go task performances	The accuracy (ACC) for go and no-go trials and reaction time (RT) of go trials were computed for each go/no-go block.	4 weeks
Secondary	the concentration of oxygenated hemoglobin within the prefrontal cortex	fNIRS was used to monitor the brain response when the participants performed a go/no-go task before and after TEAS or sham TEAS treatment. The ETG-4000 (Hitachi Medical Corporation, Japan) multichannel fNIRS system to measure the relative concentration changes in oxygenated hemoglobin (HbO), with two wavelengths of nearinfrared light (695 and 830 nm). HbO signal is more sensitive to changes in cerebral blood flow than deoxygenated hemoglobin and total hemoglobin signals. Specifically, we used a 3 × 11 multichannel patch that consisted of 17 emitters and 16 detectors arranged alternately at an inter-probe distance of 3 cm forming 52 channels.	4 weeks