Transcutaneous Electrical Acupoint Stimulation for the Treatment of ADHD

NCT03917953 | Completed

• 1 other identifier: XJTU1AF-CRF-2018-003
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Clinical Global Impression-Improvement-Severity (CGI-S) score

  4 weeks

• Conners' Parent Rating Scales-Revised: Short Form (CPRS-R: S) score

  4 weeks

• Conners' Teacher Rating Scales-Revised: Short Form (CTRS-R: S) score

  4 weeks

• go/no-go task performances

  4 weeks

• the concentration of oxygenated hemoglobin within the prefrontal cortex

  4 weeks

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive transcutaneous electrical acupoint stimulation therapy twice weekly for 4 weeks.

Device: Transcutaneous Electrical Acupoint Stimulation

Arm II

SHAM COMPARATOR

Patients receive sham transcutaneous electrical acupoint stimulation therapy twice weekly for 4 weeks.

Device: Transcutaneous Electrical Acupoint Stimulation

Interventions

Transcutaneous Electrical Acupoint Stimulation DEVICE

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 I; Arm II

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Xian Children's Hospital: collaborator
• Shaanxi Hospital of Traditional Chinese Medicine: collaborator
• Air Force Military Medical University, China: collaborator

Study Sites (1)

Xian Children's Hospital

Xi'an, Shaanxi, 710000, China

Location

Related Publications (5)

• 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.

  PMID: 26386541 BACKGROUND

• 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.

  PMID: 21509667 BACKGROUND

• 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.

  PMID: 28655016 BACKGROUND

• 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.

  PMID: 27618593 BACKGROUND

• 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: 35449191 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Yan Li, Dr.

  First Afflicated Hospital Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Children with ADHD in the 2 groups were treated in separate treatment rooms and blinded on the intervention (i.e., true or sham TEAS). The TEAS operators could not be blinded to the treatment assignments. The data collectors, outcome assessors, and statisticians were blinded to group allocations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2019
• First Posted: April 17, 2019
• Study Start: July 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: January 17, 2020
• Last Updated: March 15, 2021

Record last verified: 2021-02

Locations

CN (1)