High-density EEG Evaluation of Functional Connectivity Changes in Migraine Patients Receiving Advanced Preventive Therapies (Anti-CGRP mAbs)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) in migraine group across 6 months of mAbs treatment.
研究概览
简要总结
Migraine is a leading cause of disability with an estimated prevalence of 12% in Europe. The headache field witnessed a breakthrough since the introduction of specific preventive therapies which proved effective and well tolerated, namely the monoclonal antibodies directed against the Calcitonin Gene Related Peptide (CGRP) pathway (mAbs). Their mechanism of action is still debated. Several Authors claimed that, despite the site of action is peripheral (namely outside of the blood brain barrier), the resulting action may take place at central level. Another valuable hypothesis is that the clinical modifications resulting from mAbs treatment may induce functional modulation of several brain areas.
With these premises, the primary aim of the study is to evaluate changes in functional connectivity in patients undergoing preventive mAbs treatment using high density EEG.
详细描述
Electroencephalogram (EEG) is widely available as a powerful mean to non-invasively study brain connectivity features in migraine patients. High density EEG, by means of a minimum of 64 up to 256 electrodes, enables to record electrical brain activity with high spatial resolution. Through the analysis of brain oscillations across different frequency bands (from alpha to delta), it can evaluate sensory, pain processing and information integration, contributing to a better definition of baseline features and to detect potential markers or predictors for therapeutic interventions in an era addressed to precision medicine.
Previous neurophysiological studies focused on EEG and to assess functional connectivity or spectral analysis in migraine patients. Conventional studies found higher slow wave activity (predominantly theta) in the interictal phase and higher excitability in the visual cortex during visual aura.
In 2016 a resting state study showed a predominance of low frequency bands in the ictal phase. The interictal and ictal phases patients also presented a diffuse lower coherence, suggesting low functional connectivity. Furthermore, an altered spatial connectivity for lower alpha-band activities was found in the interictal phases during sensory stimulation by means of HD-EEG, suggesting a thalamocortical dysrhythmia.
Nowadays, targeted preventive migraine therapies are available, namely monoclonal antibodies directed against the Calcitonin Gene Related Peptide (CGRP) pathway (mAbs). They demonstrated high efficacy and tolerability in both chronic and episodic migraine. Despite their peripheral site of action (outside of the blood brain barrier), the resulting action may take place at central level or determine clinical modifications leading to a functional modulation of several brain areas.
The primary aim of the study is to evaluate changes in functional connectivity in patients undergoing preventive mAbs treatment using HD- EEG and eventual connectivity differences between Responders and Non-Responders.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Episodic or chronic migraine diagnosis according to ICHD-3 criteria
- •Indication to BoNT-A or mAbs treatment according to AIFA criteria
- •Brain MRI performed within 24 months from enrolment
排除标准
- •Previous or actual history of epilepsy
- •Diagnosis of dementia o mental retardation
- •Diagnosis of psychiatric illness according to Diagnostic and Statistical Manual of Mental Disorders V
- •Other concomitant type of headache (except for sporadic tension type headache)
- •Chronic pain conditions
- •Pregnancy or breastfeeding
- •Concomitant use of electrical stimulators, pace-makers, metallic clips or other metallic foreign bodies
- •Previous head surgery
- •Ongoing neuroactive prevention therapies or other drugs, or psicoactive substances possibly interfering with EEG recording (eg benzodiazepines)
- •Other conditions possibly influencing EEG recording
- •Brain anomalies detected on MRI
研究组 & 干预措施
HFEM or CM treated with mAbs
Patients with high frequency episodic or chronic migraine undergoing treatment with monoclonal antibodies directed against calcitonin gene related peptide pathway
干预措施: Monoclonal antibody targeting the CGRP pathway (ligand or receptor) (mAbs) (Drug)
结局指标
主要结局
Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) in migraine group across 6 months of mAbs treatment.
时间窗: Baseline (T0) - 3 months of mAbs treatment (T3) - 6 months of mAbs treatment (T6)
To compare HD-EEG functional connectivity in migraine patients across 6 months of mAbs treatment
Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in Responders vs. Non-Responders across 6 months of mAbs treatment
时间窗: Baseline (T0) - 3 months of mAbs treatment (T3) - 6 months of mAbs treatment (T6)
To compare HD-EEG functional connectivity in Responders (those who achieved a reduction of Monthly migraine days \> / = 50% compared to T0) vs. Non-Responders across 6 months of mAbs treatment
次要结局
- Baseline differences in absolute functional connectivity values (continuous variable, without unit of measurement) in Responders vs. Non-Responders(Baseline (T0))
- Baseline differences in absolute functional connectivity values (continuous variable, without unit of measurement) among patients with a baseline diagnosis of HFEM vs. CM vs. healthy controls(Baseline (T0))