Transcutaneous Electrical Acupoint Stimulation for the Treatment of ADHD

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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ADHD

Intervention / Treatment
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* Device: Transcutaneous Electrical Acupoint Stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive transcutaneous electrical acupoint stimulation therapy twice weekly for 4 weeks. | Device: Transcutaneous Electrical Acupoint Stimulation<br>* 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).<br>|
| Sham Comparator: Arm II<br>Patients receive sham transcutaneous electrical acupoint stimulation therapy twice weekly for 4 weeks. | Device: Transcutaneous Electrical Acupoint Stimulation<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |