Combined Effects of Green Light and Transcranial Direct Current Stimulation on Migraine Intensity and Frequency in Migraine Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Structured Headache Diary Data
研究概览
简要总结
According to the Global Burden of Disease (GBD) study, headache disorders are among the most prevalent and disabling conditions worldwide, with estimated 1-year prevalence of migraine (22.5%) in Pakistan, considerably higher than the global 1-year prevalence of 15%.
The treatment options comprise such as lifestyle modifications, behavioral therapy, medication such as nonsteroidal anti-inflammatory drugs (NSAIDs), beta blockers, calcium channel blockers, antiepileptic drugs or antibodies against calcitonin gene-related peptide (CGRP) or its receptor, and neuromodulation.
One of the non-invasive neuromodulation technique is used in migraine patients .i.e., transcranial direct current stimulation (tDCS), tDCS is a promising method for migraine treatment delivering a low-intensity current through the scalp by means of electrodes to modulate the state of polarization of the cerebral cortex; depending on the polarity of the electrical stimulation, tDCS can be either anodal(excitatory) or cathodal(inhibitory). Neuromodulation by tDCS is thought to follow Hebbian Theory ("neurons that fire together, wire together"). If presynaptic and postsynaptic neurons are both active, the result is synaptic strengthening; if one or both are inactive, no change occurs. The literature reported significant reduction in migraine days when applying tDCS to the occipital cortex, primary motor cortex, or the dorsolateral prefrontal cortex. The advantages of tDCS treatment are its relatively low cost compared to other neurostimulator methods, safety and generally mild side effects.
详细描述
Migraine is a common and debilitating neurological disorder, defined as "an episodic headache associated with certain features, such as sensitivity to light, sound, or movement", classified by headache frequency, with chronic migraine (CM), defined as 15 or more headache days a month for three or more months while episodic migraine (EM), is defined as occurring on fewer than 15 headache days per month.
It is also known as a common relapsing headache disease with a huge socioeconomic burden, characterized by a headache lasting 4 - 72 hours when untreated, which tends to be unilateral, pulsating, and of moderate to severe pain intensity.
According to the Global Burden of Disease (GBD) study, headache disorders are among the most prevalent and disabling conditions worldwide, with estimated 1-year prevalence of migraine (22.5%) in Pakistan, considerably higher than the global 1-year prevalence of 15%.
In the international classification of headache disorders 3rd Edition (ICHD-3), migraines may be diagnosed with aura or without aura. Migraine with aura is a complex neurological manifesting clinically as visual, somatosensory, speech or motor symptoms that precedes the headache phase. Migraine without aura is a recurrent headache disorder with specific features like unilateral, pulsating pain, nausea, and light/sound sensitivity, lasting between 4 and 72 hours.
The Graham and Wolff proposed the vascular theory for migraines, which stated that the serotonin released from the platelets in blood vessels to be the causal molecule. Because serotonin has constrictive effects on blood vessels, local cerebral blood flow is decreased, and this was thought to cause the auras that occur in migraines. After the reuptake or metabolism of this serotonin, the constricted blood vessels dilate, inducing the pain of the migraine headache.
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
- Single (Participant)
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
- •Episodic migraine or chronic migraine according to the International Headache Society
- •An average headache pain intensity of migraine episodes of ≥5 at numeric pain scale (NPS) over the 4 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
Group 3
tDCS and green light will be provided to the participants of this group along with the medications advised
干预措施: Green light (Other)
Group 3
tDCS and green light will be provided to the participants of this group along with the medications advised
干预措施: medicine (Other)
Group 4
Only advised medication will be utilized by the participants in this group
干预措施: medicine (Other)
Group 1
tDCS will applied to the participants of this group along with medication advised
干预措施: tDCS (Other)
Group 1
tDCS will applied to the participants of this group along with medication advised
干预措施: medicine (Other)
Group 2
Green light exposure will be provided to the participants of this group along with the medications advised.
干预措施: Green light (Other)
Group 2
Green light exposure will be provided to the participants of this group along with the medications advised.
干预措施: medicine (Other)
Group 3
tDCS and green light will be provided to the participants of this group along with the medications advised
干预措施: tDCS (Other)
结局指标
主要结局
Structured Headache Diary Data
时间窗: 4 week
Structured Headache Diary Data for frequency of migraine
Numeric Pain Scale
时间窗: 4 week
Numeric Pain Scale (NPS) for intensity of migraine, is a simple 0-10 tool for measuring pain intensity, where 0 is "no pain" and 10 is "worst pain
次要结局
- Multidimensional Pain Inventory(4 week)
- Migraine-Specific Quality of Life Survey(4 week)