Peripheral Electrical Stimulation for Migraine Prevention
2021年1月26日 更新者:Taipei Veterans General Hospital, Taiwan
To Investigate the Effects of Peripheral Electrical Stimulation on Cortical Imagining, Electrophysiology and Clinical Profile in Patients With Migraine
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.
研究概览
研究类型
介入性
注册 (预期的)
120
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
Migraine:
- Diagnosed as migraine by International Classification of Headache Disorder (ICHD-III) criteria
- onset before 50 years old
- 20-65 yrs.
- 4 or more migraine days per month in average
Healthy control:
- devoid of any systemic or neurological diseases
Exclusion Criteria:
- 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
- epilepsy
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
假比较器:假刺激
|
The subjects will undergo 8-week home-based peripheral electrical simulation on the median nerve.
The peripheral electrical simulation will be performed once a day for 30 minutes.
The stimulation will be active or sham depend on the group assignment.
|
|
实验性的:主动刺激
|
The subjects will undergo 8-week home-based peripheral electrical simulation on the median nerve.
The peripheral electrical simulation will be performed once a day for 30 minutes.
The stimulation will be active or sham depend on the group assignment.
|
|
无干预:健康控制
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change in migraine or headache days of a month in average
大体时间:2 months
|
change in migraine or headache days of a month in average
|
2 months
|
|
responder rate
大体时间:2 months
|
responder rate (50% pain reduction from baseline)
|
2 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change in moderate to severe headache days of a month in average
大体时间:2 months
|
2 months
|
|
|
acute headache medication use
大体时间:2 months
|
2 months
|
|
|
Beck Depression Inventory
大体时间:2 months
|
2 months
|
|
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modified Migraine Disability Scale
大体时间:2 months
|
This modified Migraine Disability Scale assesses the migraine related disability in the past 1 month.
The total score will be compared and the lower score stands for better outcome.
|
2 months
|
|
Patient/Clinical Global Impression of Change
大体时间:2 months
|
Patient/Clinical Global Impression of Change (PGIC/CGIC) are 7-point scales to assess the improvement by patients themselves and by their clinicians.
|
2 months
|
|
Sensory threshold change after treatment
大体时间:2 months
|
Using quantitative sensory testing (QST) to evaluate the sensory threshold before and after treatment
|
2 months
|
|
EEG change after treatment (1) Linear analysis of EEG before and after treatment
大体时间:2 months
|
power spectal density change of EEG before and after treatment
|
2 months
|
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EEG change after treatment (2) Nonlinear analysis of EEG before and after treatment
大体时间:2 months
|
functional connectivity change of EEG before and after treatment
|
2 months
|
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fMRI change after treatment
大体时间:2 months
|
functional connectivity change of fMRI before and after treatment
|
2 months
|
|
MRI change after treatment
大体时间:2 months
|
VBM changes of MRI before and after treatment
|
2 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2021年2月1日
初级完成 (预期的)
2022年6月30日
研究完成 (预期的)
2022年12月31日
研究注册日期
首次提交
2019年4月2日
首先提交符合 QC 标准的
2019年4月2日
首次发布 (实际的)
2019年4月3日
研究记录更新
最后更新发布 (实际的)
2021年1月29日
上次提交的符合 QC 标准的更新
2021年1月26日
最后验证
2021年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.