NCT00866411Unknown不适用
Outcomes of Cranial Electrotherapy Stimulation (CES) With Soldiers for Combat-Related Symptoms
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Irritability Visual Analog Scale
研究概览
简要总结
The purpose of this double-blind randomized control research study is to determine if CES given in a group setting for soldiers experiencing irritability is effective to reduce the symptom of irritability.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Soldiers over 18 years old or emancipated minors willing to sign an informed consent and complete all protocol requirements.
- •Soldiers who score 4 or greater on the visual analog scale for irritability
排除标准
- •Seizure disorders.
- •Pregnancy. All female Soldiers will verify in the informed consent that they are not currently pregnant. Safety of stimulation has not been established during pregnancy and therefore we will exclude women who are or want to become pregnant during the course of the study.
- •Concomitant therapy with an investigational drug or device, or participation in an investigational drug or device study within one month prior to entering this study
- •Patients with a pacemaker or implanted defibrillator. The Alpha-Stim 100 may effect the operation of cardiac pacemakers (particularly demand type pacemakers) and therefore this population will be excluded from this study.
结局指标
主要结局
Irritability Visual Analog Scale
时间窗: Baseline, daily x 3 weeks, 4 weeks
次要结局
- Sleep Self Care Questionnaire(Baseline, 3 weeks, 4 weeks)
- State Anxiety Scale(Baseline, 3 weeks, 4 weeks)
- Pittsburgh Sleep Quality Index(Baseline, 3 weeks, 4 weeks)
- Epworth Sleepiness Scale(Baseline, 3 weeks, 4 weeks)
- Medication Use Questionnaire(Baseline, 3 weeks, 4 weeks)
- Spielberger State-Trait Anger Expression Inventory-2(STAXI-2)(baseline, 3 weeks, 4 weeks)
- General Sleep Disturbance Scale(Baseline, 3 weeks, 4 weeks)
- Combat Exposure Scale(Baseline)
- Trauma Imagery Scale(Baseline, 3 weeks, 4 weeks)
- State - Anxiety Scale(Baseline, 3 weeks, 4 weeks)
- Profile of Mood States(Baseline, 3 weeks, 4 weeks)
- Visual Analog(Daily x 3 weeks, 4 weeks)
- Center for Epidemiological Center for Epidemiological Studies - Depression Scale(Baseline, 3 weeks, 4 weeks)
- Depression Visual Analog(Daily x 3 weeks, 4 weeks)
- PTSD CheckList - Military Version(Baseline, 3 weeks, 4 weeks)
- Veteran's Outcomes Survey Short Form - 36(Baseline, 3 weeks, 4 weeks)
研究者
研究点 (4)
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