Transcutaneous Electrical Acupoint Stimulation for the Treatment of ADHD

Not Applicable

Completed

• Conditions: ADHD
• Interventions: Device: Transcutaneous Electrical Acupoint Stimulation

• Registration Number: NCT03917953
• Lead Sponsor: 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.

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 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 .

Study Timeline

• Study First Submitted: 2019-04-14
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-17
• Study Start: 2019-07-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-17
• Status Verified: 2021-02
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	Transcutaneous Electrical Acupoint Stimulation	Patients receive transcutaneous electrical acupoint stimulation therapy twice weekly for 4 weeks.
Arm II	Transcutaneous Electrical Acupoint Stimulation	Patients receive sham transcutaneous electrical acupoint stimulation therapy twice weekly for 4 weeks.

Primary Outcome Measures

Name	Time	Method
the investigator-rated Clinical Global Impression-Improvement (CGI-I) scores	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Conners' Parent Rating Scales-Revised: Short Form (CPRS-R: S) score	4 weeks	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.
Conners' Teacher Rating Scales-Revised: Short Form (CTRS-R: S) score	4 weeks	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.
Clinical Global Impression-Improvement-Severity (CGI-S) score	4 weeks	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.
go/no-go task performances	4 weeks	The accuracy (ACC) for go and no-go trials and reaction time (RT) of go trials were computed for each go/no-go block.
the concentration of oxygenated hemoglobin within the prefrontal cortex	4 weeks	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.

Trial Locations

Locations (1)

Xian Children's Hospital; 🇨🇳 Xi'an, Shaanxi, China