Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Mean Headache Days
研究概览
简要总结
Cranial electrotherapy stimulation (CES) may be a safe adjunct to medical treatment for pain relief in migraine patients. However, despite the number of CES studies done, many have been open label, single blinded, or have utilized a small group of patients.
详细描述
This study will evaluate the efficacy of the Fisher Wallace Cranial Stimulator in persons with chronic migraine who have not achieved satisfactory pain control on their current medications.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects satisfying the IHS (International Headache Society) criteria for migraine
- •Subjects have not achieved satisfactory pain control on their current medication
- •Ability to maintain a daily headache diary
- •Stable medication use related to migraine for at least 4 weeks prior to enrollment in the study
排除标准
- •Previous exposure to or experience with cranial electrotherapy stimulation (CES)
- •Contraindications to Fisher Wallace stimulator, such as cardiac pacemakers or implantable defibrillators, known or suspected heart disease, or pregnancy
- •Seizure disorders
结局指标
主要结局
Mean Headache Days
时间窗: 28 day period during run-in month and blinded month
Mean change in headache days between 28 day run-in month and 28 day blinded month, i.e. run-in month mean minus blinded month mean. A good response is \>= 50% reduction in headache days (congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache).
Depression Score (PATIENT HEALTH QUESTIONNAIRE [PHQ] 9)
时间窗: 14 days recall; measured at end of run-in month and blinded month
Mean difference of PHQ-9 score between the run-in month and blinded month, i.e. PHQ-9 score from run-in month minus blinded month. The PHQ-9 is a tool for assisting in diagnosing depression (over the prior 2 week period) as well as selecting and monitoring treatment. There are nine items, with responses each ranging from 0 (not at all) to 3 (nearly every day), for a total range of 0 to 27. The higher the total the more severe the depressive symptoms.
次要结局
- Headache Days(28 day period in run-in month and open label month)
- Depression Score (Patient Health Questionnaire-9)(14 day recall, recorded at the end of run-in and open label months)
- Headache Impact Test-6(after run-in month, after blinded month)
- Headache Impact Test (HIT-6) (Measure of Disability Due to Headaches)(28 day period in run-in month and open label month)
- Generalized Anxiety Disorder Score (GAD 7)(14 day recall, recorded at the end of run-in and open label months)
- Epworth Sleepiness Scale Score(Score recorded at the end of run-in and open label month)
- Somatic Symptom Severity (Patient Health Questionnaire 15)(28 days recall; measured at end of run-in month and blinded month)
- Somatic Symptom Score (Patient Health Questionnaire-15)(28 day period in run-in month and open label month)
研究者
Gretchen Tietjen, MD
Principal Investigator
University of Toledo Health Science Campus