Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- RSN-FC assessed through HD-EEG
研究概览
简要总结
The investigators aim to define the neurofunctional phenotype of migraine patients who did not respond to at least 3 preventive treatments, including monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) pathway (NON-responders).
Primary aim will be to assess and compare changes in functional resting-state connectivity at baseline and after three months of mAbs treatment between patients who will achieve a reduction of monthly migraine days >/= than 50% (namely Responders) and those who will not (namely Responders).
The 2 groups will undergo a neurofunctional profile by means of High Density-electroencephalogram (HD-EEG) and functional-magnetic resonance imaging (fMRI).
详细描述
High Density-electroencephalogram (HD-EEG) and functional-magnetic resonance imaging (fMRI) are widely available as powerful means to non-invasively study brain connectivity features in migraine patients.
They both enables to record brain activity with high spatial resolution. HD-EEG also contributes to high temporal resolution, while fMRI contributes to precise evaluation of deep cortical and subcortical areas, relevant in migraine pathophysiology.
Aim of the study is to evaluate changes in resting-state functional connectivity in patients undergoing preventive mAbs treatment using HD- EEG and fMRI. These findings will allow the identification of a multibiomarkers panel signature of migraine patients resisting to specifically targeted preventive treatments and potentially unveiling other molecular targets for therapeutic approaches.
STUDY DESIGN:
This study is part of the SPHERA project receiving funding from the Italian Ministry of Health (GR-2021-12372429). Patients will be enrolled from those attending the outpatient clinic of IRCCS Mondino Institute (Pavia) and Neurology Department of the University of L'Aquila (Avezzano).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female patients aged 18 to 75 years
- •diagnosis of episodic migraine or chronic migraine according to ICHD-3 criteria
- •for episodic migraine: 8-14 monthly migraine days in the previous 3 months
- •diagnosis of resistant migraine, defined by having failed at least 3 classes of migraine preventatives and suffer from at least 8 debilitating monthly headache days for at least 3 consecutive months
- •patients naive to CGRP targeting treatments
排除标准
- •history of major psychiatric or other neurological conditions
- •diagnosis of other primary or secondary headache disorders (only sporadic tension-type headache is allowed if the patients can clearly differentiate between the 2 types of headaches)
- •changes in ongoing preventive treatment (if any) in the previous 3 months
- •clinically significant medical conditions
- •chronic pain conditions
- •alcohol and/or drug abuse
- •pregnancy or lactation
研究组 & 干预措施
Responders
Patients with high frequency episodic or chronic migraine undergoing treatment with monoclonal antibodies directed against calcitonin gene related peptide pathway (mAbs) who obtained a reduction in monthly migraine days equal or higher than 50% compared to pre-treatment values.
干预措施: MAbs (Drug)
NON-Responders
Patients with high frequency episodic or chronic migraine undergoing mAbs treatment who obtained a reduction in monthly migraine days < 50% compared to pre-treatment values.
干预措施: MAbs (Drug)
结局指标
主要结局
RSN-FC assessed through HD-EEG
时间窗: Baseline (T0), and three months of mAbs treatment (T1)
Resting state functional connectivity assessed through HD-EEG (continuous variable, without unit of measurement)
RSN-FC assessed through MRI
时间窗: Baseline (T0)
Resting state functional connectivity assessed through MRI (continuous variable, without unit of measurement)
次要结局
- Comparison between baseline RSN-FC assessed through HD-EEG(Baseline (T0))
- Comparison between baseline RSN-FC assessed through MRI(Baseline (T0))