Decoding Pain Sensitivity in Migraine With Multimodal Brainstem-based Neurosignature
研究概览
详细说明
Migraine causes a tremendous disease burden around the world. Migraine is one of the most prevalent neurological disorders and is reported by the WHO as the second leading cause of disease-related disabilities globally (No. 1 in the population under the 50s). There has been no much change in the ranking of disability for migraine for the past two decades, reflecting an unmet need for better treatment options. Even with the recently available calcitonin-gene related peptide (CGRP)-based treatment, the treatment response versus placebo is still disappointing (6.4-17.6% in acute treatment, 10.2-23.7% in preventive treatment). There is an urgent need to push further the current understanding of the pathophysiology of migraine, based on which novel treatment strategies can be developed. The lack of appropriate research tools hinders the acceleration of migraine research. As a neurological disorder, many neuroimaging studies have been focused on brain alterations; however, the majority focused on the cerebrum. Limited by the currently available neuroimaging and electrophysiological technologies, the deep brain structures especially the brainstem involved in the sensory and nociceptive neurotransmission in migraine, such as the trigeminal nucleus, could only be investigated to a limited extent. Obviously, there is an unmet need for novel technologies that can be used to delineate structural or functional alterations in the brainstem. Elucidation of the role of these deep brain structures may fill the gap in the current understanding of migraine pathophysiology, and pave the way to precise and efficient treatment. Studies restricted to single methodologies are insufficient for the complexity of migraine. Migraine is a complex and dynamic disorder. However, most prior studies were limited to single methodologies and provided limited insights into such a multifaceted disorder. Studies with an integrated approach are lacking. An exhaustive examination of the discrete components of a phenotype, i.e., 'deep phenotyping', can help understand different aspects of its clinical manifestations, and facilitate patient classification. Coupled with neuroimaging and electrophysiological research methodologies, a multi-modal decoding approach would help identify a constellation of migraine-specific biosignatures, rather than just one. This can not only provide clues to decipher migraine pathophysiology in various dimensions but also serve as the basis of the development of a prediction algorithm that can be applied in clinical practice. To pursue the overall goal, the present project schemes as a composition of the following 5 aims:
Aim 1: Deep phenotyping for sensory processing in patients with migraine Aim 2: Brainstem-based functional and structural connectomics in migraine Aim 3: Capturing brainstem electro-neurosignature in migraine Aim 4: Constructing a data fusion platform and developing an EEG cap with a built-in analytic chip Aim 5: Exploring brainstem-based connectome sequencing in migraine animal model
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名:Shuu-Jiun Wang
- 电话号码:28712121
- 邮箱:k123wang@gmail.com
研究联系人备份
- 姓名:Li-Ling Pan
- 邮箱:hope881212@hotmail.com
学习地点
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Taipei、台湾、112
- 招聘中
- Headache Center, Teipei Veterans General Hospital
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接触:
- Shuu-Jiun Wang, MD
- 电话号码:7578 +886-2-28712121
- 邮箱:sjwang@vghtpe.gov.tw
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接触:
- Li-Ling Pan, Ph.D.
- 电话号码:1291 +886-2-28712121
- 邮箱:hope881212@hotmail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Migraine:
Inclusion criteria:
- fulfill the diagnostic criteria of migraine in ICHD-3,
- 20-65 yrs,
- understand the study design and willing to join the study
- at least four headache days per month,
- the onset of headache is prior to 50 yrs.,
- normal neurological examination findings.
Exclusion criteria:
- history or family history of epilepsy,
- taking migraine prophylactics,
- women who are breastfeeding or pregnant,
- severe psychological disorders, including major depression, PTSD, personality disorders, bipolar disorder, schizophrenia,
- medical, neurological or psychiatric disease discovered by the researcher that would hinder the research,
- contraindications for MR scan (pacemaker, claustrophobia, stent, metal implants…).
Healthy:
Inclusion criteria:
- 20-65 yrs,
- normal neurological examination findings,
- understand the study design and willing to join the study.
Exclusion criteria:
- history or family history of epilepsy,
- women who are breastfeeding or pregnant,
- severe psychological disorders, including major depression, PTSD, personality disorders, bipolar disorder, schizophrenia,
- medical, neurological or psychiatric disease discovered by the researcher that would hinder the research,
- contraindications for MR scan (pacemaker, claustrophobia, stent, metal implants…),
- history of headache will be included (the tension-type headache occurs < 1 time per month is allowed)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:patients with migraine
patient with migraine will be prescribed with flunarizine or routine clinical care per clinician's decision based on the condition of each individual patient
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The flunarizine will be given per clinical routine
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其他:healthy control
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no intervention for healthy control
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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 |
|---|---|---|
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Clinical change after treatment (1) headache frequency
大体时间:6 months
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clinical change (headache frequency) after treatment unit: attacks per month analysis: comparing the mean headache frequency in each month after treatment (M1/M2/M3/M4/M5/M6) to that before treatment (M0)
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6 months
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Clinical change after treatment (2) headache intensity
大体时间:6 months
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clinical change (headache intensity) after treatment unit: NRS (numeric rating scale, 0-10) analysis: comparing the mean headache intensity in each month after treatment (M1/M2/M3/M4/M5/M6) to that before treatment (M0)
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6 months
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Clinical change after treatment (3) headache duration
大体时间:6 months
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clinical change (headache duration) after treatment unit: hours/day analysis: comparing the mean headache duration (hours/day) in each month after treatment (M1/M2/M3/M4/M5/M6) to that before treatment (M0)
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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EEG change after treatment (1) Linear analysis of EEG before and after treatment
大体时间:12 months
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power spectral density change of EEG before and after treatment • Four EEG sessions will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively. |
12 months
|
|
EEG change after treatment (2) Nonlinear analysis of EEG before and after treatment
大体时间:12 months
|
functional connectivity change of EEG before and after treatment • Four EEG sessions will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively. |
12 months
|
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EEG change after treatment (3) Nonlinear analysis of EEG before and after treatment
大体时间:12 months
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evoked potential amplitude change of EEG before and after treatment • Four EEG sessions will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively. |
12 months
|
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Sensory threshold change after treatment
大体时间:12 months
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Using quantitative sensory testing (QST) to evaluate the sensory threshold before and after treatment • Four standard QST sessions will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively. |
12 months
|
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fMRI change after treatment (1)
大体时间:12 months
|
functional connectivity change of fMRI before and after treatment • Three fMRI sessions will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 6-month/12-month treatment course, respectively. |
12 months
|
|
fMRI change after treatment (2)
大体时间:12 months
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activation change of fMRI before and after treatment • Three fMRI sessions will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 6-month/12-month treatment course, respectively. |
12 months
|
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MRI change after treatment (1)
大体时间:12 months
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VBM changes of MRI before and after treatment • Three MRI sessions will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 6-month/12-month treatment course, respectively. |
12 months
|
|
MRI change after treatment (2)
大体时间:12 months
|
SBM changes of MRI before and after treatment • Three MRI sessions will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 6-month/12-month treatment course, respectively. |
12 months
|
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Humoral change after treatment (1)
大体时间:12 months
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Test the cytokine level using ELISA kit to evaluate the status before and after treatment • Four blood test sessions and saliva collection will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively. |
12 months
|
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Humoral change after treatment (2)
大体时间:12 months
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Test the hormone level using ELISA kit to evaluate the status before and after treatment • Four blood test sessions and saliva collection will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively. |
12 months
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Genetic variance
大体时间:5 minutes
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Genetic variants associated with baseline demographics and treatment response as assessed with genome-wide association study using the genotyping data derived from the Axiom Genome-wide array • Blood draw before the treatment to extract DNA for further sequencing |
5 minutes
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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