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Physiopathology, Diagnosis and Therapy of Primary Cephalalgia and Adaptive Disorders

2021年1月5日 更新者：IRCCS National Neurological Institute "C. Mondino" Foundation

Biomarker Identification to Predict the Evolution of Migraine From an Episodic to a Chronic Condition

The main aim of the present pilot study is to prove the possibility to use the Nitroglycerin (NTG) model to describe the pathophysiology of headache using task-free advanced Magnetic Resonance Imaging (MRI) techniques, in order to depict the static changes of the ictal and inter-ictal phase of migraine attacks vs the pain free state in healthy subjects and to compare that with the spontaneous headache attack experienced by chronic migraineurs.

研究概览

地位

完全的

条件

详细说明

Resting state functional magnetic resonance imaging (rs-fMRI) has depicted cyclical functional connectivity changes during the ictal and inter-ictal phase of the migraine attack. In this pilot study, Functional Connectivity (FC) changes during nitroglycerin (NTG) induced migraine attacks were assessed vs the pain-free condition in healthy subjects.

To this end, subjects with episodic migraine (EM) without aura were enrolled. NTG-triggered a spontaneous-like migraine attack in the subjects. They underwent 4 rs-fMRI scan repetitions during different phases of the attack (baseline, prodromal, full blown, recovery phase) with a 3 Tesla MR scanner. According to the pain field literature, several regions of interests were studied, in particular the thalamic areas and the salience network (SN) were selected as primary areas of interest for the analyses. Subjects' rs-fMRI data were first processed with a seed-based correlation analysis (SCA) to assess the static changes in FC between the thalamus and the rest of the brain during the experiment. The wavelet coherence approach (WCA) were also applied to test the changes in time-in-phase coherence between the thalamus and the salience network (SN).

Healthy subject were administered nitroglycerin as well and scanned at a pain free baseline and after 3 hours in order to compare the response.

The rebound headache that followed acute drug withdrawal were used as a surrogate paradigm of spontaneous attack. Patients with chronic migraine and medication overuse were hospitalized for a supervised withdrawal program at the Mondino Foundation; during the program if they experienced a rebound headache attack, they were scanned with a rs-fMRI acquisition.

The acquired imagines were analyzed with the same procedure regarding the evaluation of static and dynamic functional connectivity fluctuation.

研究类型

观察性的

注册 (实际的)

15

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。

学习地点

  • 意大利
      • Pavia、意大利、27100
        • Headache Science Center

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

18年 至 60年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Subjects with episodic migraine without aura; patients with chronic migraine and medication overuse; healthy subjects

描述

Episodic migraineurs

Inclusion Criteria:

  • age between 18-60 years;
  • diagnosis of episodic migraine without aura developed before the age of 50;
  • no current prophylactic treatment for migraine prevention;
  • chronic migraineurs with medication overuse according to the ICHDIII criteria

Exclusion Criteria:

  • chronic or medication-overuse headache or cluster headache diagnosis;
  • any chronic pain condition or disorders other than migraine;
  • an alleged diagnosis of major psychiatric disorders such as depression, bipolar affective disorder and schizophrenia;
  • a diagnosis of tension type headache with a frequency of more than 5 days per month;
  • any cardiovascular diseases in which the NTG use could be contraindicated;
  • blood pressure hypotension, closed angle glaucoma, anaemia;
  • women in child bearing, breast feeding; continuous use of benzodiazepines;
  • any neuroradiological pathological findings at a previous MRI scan of the head.

Chronic migraineurs

Inclusion Criteria:

  • age between 18-60 years;
  • diagnosis of migraine without aura developed before the age of 50 according to the ICHD III criteria;
  • currently chronic migraineurs with medication overuse according to The International Classification of Headache Disorders 3rd edition (ICHDIII) criteria.

Exclusion Criteria:

  • any chronic pain condition or disorders other than migraine;
  • an alleged diagnosis of major psychiatric disorders such as depression, bipolar affective disorder and schizophrenia;
  • a diagnosis of tension type headache with a frequency of more than 5 days per month;
  • any cardiovascular diseases in which the NTG use could be contraindicated;
  • blood pressure hypotension, closed angle glaucoma, anaemia; women in child bearing, breast feeding;
  • continuous use of benzodiazepines;
  • any neuroradiological pathological findings at a previous MRI scan of the head.

Healthy subjects

Inclusion Criteria:

  • age between 18-60 years;
  • overall good clinical condition, no neurological findings at the physical examination.

Exclusion criteria:

  • history of episodic or chronic or medication-overuse headache or cluster headache diagnosis according to the International Chronic Headache Disease (ICHD) III criteria;
  • any chronic pain condition or disorders other than migraine;
  • an alleged diagnosis of major psychiatric disorders such as depression, bipolar affective disorder and schizophrenia;
  • a diagnosis of tension type headache with a frequency of more than 5 days per month;
  • any cardiovascular diseases in which the NTG use could be contraindicated;
  • blood pressure hypotension, closed angle glaucoma, anaemia;
  • women in child bearing, breast feeding;
  • continuous use of benzodiazepines;
  • any neuroradiological pathological findings at the baseline MRI scan of the head.

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

队列和干预

团体/队列
Chronic migraineurs
This group includes patients with chronic migraine.
Control group
This group includes healthy subjects.
Episodic migraineurs
This group includes patients with episodic migraine

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
Functional Connectivity (FC) changes
大体时间：Up to 6 hours
Functional connectivity pattern of changes profiling the different condition of the migraine experience. To depict the static and dynamics changes of brain activity during a migraine attack; ii) To validate the use of the NTG-induced attacks paradigm as a reliable instrument combined with an fMRI approach to compare the induced vs the spontaneous attack; iii) To describe possible differences in brain activity between attacks in chronic and episodic migraineurs.
Up to 6 hours

次要结果测量

结果测量
措施说明
大体时间
Magnetic Resonance Imaging (MRI)
大体时间：Up to 6 hours
To acquire sufficient MRI to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms. This can be achieved by combining clinical, psychological, biological, neurophysiological and MRI-derived features into a multimodal multi-parametric approach suitable for patient's classification. The ML and DL approaches could also be adopted to predict chronification, as well as the response to a withdrawal program for medication overuse headache.
Up to 6 hours
Monthly migraine frequency (day/month)
大体时间：Up to 6 hours
To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours
Disease duration (years)
大体时间：Up to 6 hours
To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours
Nausea (number)
大体时间：Up to 6 hours
As a feature of the migraine attack.To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours
Vomiting (number)
大体时间：Up to 6 hours
As a feature of the migraine attack.To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours
Photophobia (number)
大体时间：Up to 6 hours
As a feature of the migraine attack.To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours
Phonophobia (number)
大体时间：Up to 6 hours
To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours
Aggravation by movement (number)
大体时间：Up to 6 hours
As a feature of the migraine attack. To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours
Throbbing pain (number)
大体时间：Up to 6 hours
As a feature of the migraine attack. To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours
Abortive medication (number of intake/month)
大体时间：Up to 6 hours
To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours

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。

赞助

IRCCS National Neurological Institute "C. Mondino" Foundation

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2018年8月31日

初级完成 (实际的)

2019年3月31日

研究完成 (实际的)

2020年12月15日

研究注册日期

首次提交

2020年12月21日

首先提交符合 QC 标准的

2021年1月5日

首次发布 (实际的)

2021年1月6日

研究记录更新

最后更新发布 (实际的)

2021年1月6日

上次提交的符合 QC 标准的更新

2021年1月5日

最后验证

2020年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IMAGO2020

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

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