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Decoding Pain Sensitivity in Migraine With Multimodal Brainstem-based Neurosignature

2021年4月9日 更新者:Taipei Veterans General Hospital, Taiwan
Migraine is a highly prevalent and disabling neurological disease, which has a tremendous impact on sufferers, healthcare systems, and the economy. According to the 2016 WHO report, migraine is the second leading cause of years lived with disability, greater than all other neurological diseases combined. Yet, the treatment in migraine is far from optimum; the sufferers often abuse painkillers and complicated with medication overuse headache. Migraine is characterized by the hypersensitivity of the sensory system, potentially attributed to dysfunctional pain modulatory networks located in the deep brain structures, particularly the brainstem. However, the current understanding of these deeply seated, dysregulated pain modulatory circuits in migraine is limited due to technological constraints. Besides, studies with an in-depth analysis of the clinical manifestations (i.e., deep phenotyping) are lacking, and there is no corresponding animal model readily available for translational research. In this project, the investigators propose a multimodal approach to address these issues by applying the technologies and platforms developed by our team to explore the correlation between pain sensitivity and dysregulated connectivities from brainstem to other brain regions. In this four-year project, the investigators will recruit 400 migraine patients and 200 healthy subjects. The investigators aim at decomposing the key brainstem mechanisms underlying dysmodulated pain sensitivity in migraine from 5 comprehensive perspectives: (1) clinical deep phenotyping, (2) high-resolution brainstem structural MRI and functional connectivity analysis, (3) innovative brainstem EEG signal detecting technique, (4) multimodal data fusion platform with neural network analysis, and (5) ultrahigh-resolution brainstem-based connectomes, intravital manipulations and recording, and connectome-sequencing in animal models. Moreover, the investigators will collaborate with Taiwan Semiconductor Research Institute to develop a wearable high-density EEG equipment, integrated with a System-on-Chip capable of edge-computing the signal using algorithms derived from our brainstem decoding platform. The ultimate goal is to build a real-time brainstem decoding system for clinical application.

研究概览

地位

招聘中

条件

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

介入性

注册 (预期的)

600

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Taipei、台湾、112
        • 招聘中
        • Headache Center, Teipei Veterans General Hospital
        • 接触:
        • 接触:

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

不

有资格学习的性别

全部

描述

Migraine:

Inclusion criteria:

  1. fulfill the diagnostic criteria of migraine in ICHD-3,
  2. 20-65 yrs,
  3. understand the study design and willing to join the study
  4. at least four headache days per month,
  5. the onset of headache is prior to 50 yrs.,
  6. normal neurological examination findings.

Exclusion criteria:

  1. history or family history of epilepsy,
  2. taking migraine prophylactics,
  3. women who are breastfeeding or pregnant,
  4. severe psychological disorders, including major depression, PTSD, personality disorders, bipolar disorder, schizophrenia,
  5. medical, neurological or psychiatric disease discovered by the researcher that would hinder the research,
  6. contraindications for MR scan (pacemaker, claustrophobia, stent, metal implants…).

Healthy:

Inclusion criteria:

  1. 20-65 yrs,
  2. normal neurological examination findings,
  3. understand the study design and willing to join the study.

Exclusion criteria:

  1. history or family history of epilepsy,
  2. women who are breastfeeding or pregnant,
  3. severe psychological disorders, including major depression, PTSD, personality disorders, bipolar disorder, schizophrenia,
  4. medical, neurological or psychiatric disease discovered by the researcher that would hinder the research,
  5. contraindications for MR scan (pacemaker, claustrophobia, stent, metal implants…),
  6. history of headache will be included (the tension-type headache occurs < 1 time per month is allowed)

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: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
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
The flunarizine will be given per clinical routine
其他:healthy control
no intervention for healthy control

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
Clinical change after treatment (1) headache frequency
大体时间:6 months
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)
6 months
Clinical change after treatment (2) headache intensity
大体时间:6 months
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)
6 months
Clinical change after treatment (3) headache duration
大体时间:6 months
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
EEG change after treatment (1) Linear analysis of EEG before and after treatment
大体时间:12 months

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
EEG change after treatment (3) Nonlinear analysis of EEG before and after treatment
大体时间:12 months

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
Sensory threshold change after treatment
大体时间:12 months

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
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

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
MRI change after treatment (1)
大体时间:12 months

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
Humoral change after treatment (1)
大体时间:12 months

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
Humoral change after treatment (2)
大体时间:12 months

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
Genetic variance
大体时间:5 minutes

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

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 (实际的)

2021年2月26日

初级完成 (预期的)

2024年12月1日

研究完成 (预期的)

2025年12月1日

研究注册日期

首次提交

2020年11月25日

首先提交符合 QC 标准的

2021年1月8日

首次发布 (实际的)

2021年1月11日

研究记录更新

最后更新发布 (实际的)

2021年4月14日

上次提交的符合 QC 标准的更新

2021年4月9日

最后验证

2021年4月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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