To Investigate the Effects of Peripheral Electrical Stimulation on Cortical Imagining, Electrophysiology and Clinical Profile in Patients With Migraine
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- responder rate
研究概览
简要总结
Migraine is a common and disabling disease that affects more than 10% of the population worldwide. The prevalence of migraine in Taiwan is around 9.1%. The migraineurs missed 2 workdays due to migraine per year, that is 3.7 million estimated missed workdays in total and an estimated cost of 4.6 billion New Taiwan dollars. In addition, some migraineurs have poor response to the medications or suffer from adverse effects, and may further develop medication-overuse headache. Therefore, in recent years, efforts have been made to develop non-medication treatments, and the number of studies using neuromodulation as an intervention has increased dramatically. Among them, peripheral electrical stimulation has long been a routine treatment for pain in the clinic, and research has also shown its good evidence. In addition, recent studies have shown that peripheral electrical stimulation can also alter the cortical activities. Compared with the proximal brain stimulation, the remote electrical stimulation is safer, more convenient, less expensive and suitable for home use. To date, only one research had focused on the immediate anesthetic effect of remote electrical stimulation whereas the research for migraine prevention is still absent. Therefore, we expect to utilize a more remote electrical stimulation than trigeminal nerve electrical stimulation, which is the commonly used research method nowadays, as an interventional model. In three years, we will recruit 80 migraineurs along with 40 healthy controls and investigate the effects of 8-week home-based remote electrical stimulation on the prevention of migraine and the mechanisms using brain imaging, electrophysiological and biochemical examinations. We also aim to identify the predictors of the responders to remote electrical stimulation. If the effects of remote electrical stimulation are confirmed, as a non-drug neuromodulation management with features of non-invasive, low adverse effects and high accessibility, it will greatly lower the cost of social health care and better improve the quality of life and clinical status of the migraineurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Migraine:
- •Diagnosed as migraine by International Classification of Headache Disorder (ICHD-III) criteria
- •onset before 50 years old
- •4 or more migraine days per month in average
- •Healthy control:
- •devoid of any systemic or neurological diseases
排除标准
- •history of major systemic illness, including uncontrolled hypertension, diabetes, chronic renal insufficiency, autoimmune diseases or malignancies
- •history of neurological disorders which might affect sensation such as previous stroke or peripheral neuropathy
- •pregnancy or lactation
- •moderate depressed (BDI>20)
- •using prophylactics for migraine
- •other remote electrical stimulation contraindications, such as open wound, sensory impairment, metal implant
- •other transcranial magnetic stimulation contraindications, such as, high intracranial pressure, cochlear implant, cranial metal implant
- •other magnetic resonance imaging contraindications, such as, pacemaker, stent, metal implant, claustrophobia
结局指标
主要结局
responder rate
时间窗: 2 months
responder rate (50% pain reduction from baseline)
change in migraine or headache days of a month in average
时间窗: 2 months
change in migraine or headache days of a month in average
次要结局
- acute headache medication use(2 months)
- Beck Depression Inventory(2 months)
- modified Migraine Disability Scale(2 months)
- Sensory threshold change after treatment(2 months)
- EEG change after treatment (2) Nonlinear analysis of EEG before and after treatment(2 months)
- EEG change after treatment (1) Linear analysis of EEG before and after treatment(2 months)
- change in moderate to severe headache days of a month in average(2 months)
- fMRI change after treatment(2 months)
- MRI change after treatment(2 months)
- Patient/Clinical Global Impression of Change(2 months)