Green Light and Transcranial Direct Current Stimulation in Migraine Patients; a Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Multidimensional pain inventory (MPI) for migraine impact
研究概览
简要总结
There is a lack of evidence on the clinical outcome of green light exposure, as it is the emerging, novel proposal of treatment. There are a lot of researches present with small sample size which should be done on large population. In last conducted studies, session numbers of the applied modality are less. There is no comparison of tDCS with green light for migraine. The literature suggested the neuromodulation influenced by these interventions that may result in reduction of migraine.
详细描述
Migraine treatments encompass both medicinal options, such as acute and preventive medications, as well as a variety of non-pharmacological therapies. The range of acute medications that are available can be categorized into four different treatment approaches for treating mild to moderate-severity attacks, which involve the use of acetaminophen and/or NSAIDs. For patients experiencing severe attacks or those who do not respond to the initial strategy, a triptan-based strategy is recommended. According to the American Academy of Neurology (AAN), there is strong supporting evidence for the effectiveness of several medications in preventing migraines, including metoprolol, timolol, propranolol, divalproex sodium, sodium valproate, and topiramate. There are some non-pharmacological approaches present like non-invasive and invasive neuromodulation. In non-invasive treatment, transcutaneous cranial nerve stimulation, vagus nerve stimulation, single-pulse transcranial magnetic stimulation (sTMS), transcranial direct current stimulation (tDCS), percutaneous mastoid stimulation and non-painful brachial electric stimulation are involved. In invasive neuromodulation, occipital nerve stimulation, sphenopalatine ganglion stimulation, and high cervical spine cord stimulation are involved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Meet the diagnostic criteria established by the International Headache Society,
- •patient must have had at least 5 headache attacks that lasted 4-72 hours (untreated or unsuccessfully treated)
- •headache must have had at least 2 of the following characteristic; Unilateral location & Pulsating quality,
- •An average headache pain intensity of migraine episodes of ≥5 at numeric pain scale (NPS) over the 10 weeks prior to enrolling in the study.
排除标准
- •Mental illness,
- •Photophobic individual,
- •Presence of shunt and/or implant at the cranial region,
- •Brain tumors,
- •Wound at skull
研究组 & 干预措施
tDCS Group
active tDCS with the prescribed medications for 20 minute. The intervention will conduct 3 consecutive days in a week.
干预措施: Transcranial direct current stimulation (Device)
Sham tDCS Group
sham tDCS with the prescribed medications for 20 minute. The intervention will conduct 3 consecutive days in a week.
干预措施: Sham transcranial direct current stimulation (Device)
Green Light Group
green light exposure with the prescribed medications for 1-2 hour. The intervention will conduct 5 days in a week.
干预措施: Green light (Device)
结局指标
主要结局
Multidimensional pain inventory (MPI) for migraine impact
时间窗: Week 4
Multidimensional Pain Inventory (MPI) is one of the most widely used multidimensional instruments to measure adaptation to pain. It is a self-administered questionnaire comprising 12 empirically derived scales that measure dimensions of pain perception, life interference due to pain, perception of life control, affective distress, and social support. The instrument uses a clustering approach to derive three distinct subgroups: Dysfunctional (Dys), interpersonally distressed (ID), and adaptive copers (AC).
Numeric Pain Scale (NPS) for intensity of migraine
时间窗: Week 4
NPS was implemented in clinical practice due to its rapidity both verbally and in writing. Due to its convenience, it is common for hospitals to measure pain using the 0 to 10 NPS scale.
Structured Headache Diary Data for frequency of migraine
时间窗: Week 4
diaries make it possible to record prospectively the characteristics of every attack and the use of headache calendars is indicated for evaluating the time pattern of headache, identifying aggravating factors and evaluating the efficacy of preventive treatment. This may reduce the recall bias and increase accuracy in the description.
次要结局
- Migraine-specific Quality of Life Survey (MSQ 2.1) for quality of life(Week 4)