Transcutaneous Electrical Acupoint Stimulation for Treating Attention Deficit Hyperactivity Disorder: A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- the investigator-rated Clinical Global Impression-Improvement (CGI-I) scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients have a history of illness that concomitant with other mental and neurological disorders.
- •Patients's IQ score are lower than
- •Patients have had prior TEAS or other acupoints-associated treatment experiences.
- •Left handedness.
结局指标
主要结局
the investigator-rated Clinical Global Impression-Improvement (CGI-I) scores
时间窗: 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.
次要结局
- 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)
- Clinical Global Impression-Improvement-Severity (CGI-S) score(4 weeks)
- go/no-go task performances(4 weeks)
- the concentration of oxygenated hemoglobin within the prefrontal cortex(4 weeks)