The Role of Resting State Networks Connectivity in Cluster Headache: a HD-EEG Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Difference in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) in episodic cluster headache patients between active and remission phases
研究概览
简要总结
Cluster headache is a highly disabling primary headache disorder, characterized by severe, excruciating, recurrent unilateral headache attacks. Typically, attacks' onset displays a circadian rhythm, and bout recurrence happens in a circannual fashion. Notably, the mechanisms underlying the shift between the remission phase and cluster bout are poorly understood.
Thus, the investigators aim to study brain connectivity in episodic cluster headache patients. Additionally, an explorative analysis of functional connectivity in chronic cluster headache patients will be performed.
详细描述
Electroencephalogram (EEG) is widely available as a powerful mean to non-invasively study brain connectivity. High density EEG (HD-EEG), enables to record electrical brain activity with high temporal and 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, thus detecting potential markers or predictors for therapeutic interventions.
Previous neurophysiological studies focused on EEG and to assess functional connectivity or spectral analysis in migraine patients, with no data in cluster headache. Conventional studies found higher slow wave activity (predominantly theta) in the inter-ictal 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.
The primary aim of the study is to evaluate changes in functional connectivity in episodic cluster headache patients, comparing the active phase with the remission phase. Additionally, an explorative analysis of functional connectivity in chronic cluster headache patients will be performed.
Study design:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of 3.1.1 episodic cluster headache, or 3.1.2 chronic cluster headache, according to the International Classification of Headache Disorders-3 (ICHD-3) criteria
- •History of at least 1 year of disease
- •For the active-phase recording (T0) in eCH, no preventive medication ongoing or verapamil at a stable dose for at least 2 weeks
- •For the remission-phase recording (T1), no preventive medication ongoing, and at least 14 headache-free days since preventive discontinuation
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 psychoactive substances possibly interfering with EEG recording (eg benzodiazepines)
- •Other conditions possibly influencing EEG recording
- •Brain anomalies detected on MRI
- •Healthy controls (HCs)
- •Inclusion Criteria:
- •Age and sex-matched healthy volunteers, without history of headache disorders except sporadic tension-type headache according to ICHD-3 criteria
- •Exclusion Criteria:
- •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
- •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 psychoactive substances possibly interfering with EEG recording (eg benzodiazepines)
- •Other conditions possibly influencing EEG recording
结局指标
主要结局
Difference in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) in episodic cluster headache patients between active and remission phases
时间窗: Through study completion, an average of 2 years
To compare HD-EEG functional connectivity in episodic cluster headache patients between the two phases of the disease
Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) between episodic cluster headache patients and healthy controls
时间窗: Through study completion, an average of 2 years
To compare HD-EEG functional connectivity between episodic cluster headache patients in the two phases of the disease and healthy controls
次要结局
- Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) between episodic cluster headache patients and chronic cluster headache patients(Through study completion, an average of 1 year)
- Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) between chronic cluster headache patients and healthy controls(Single evaluation in chronic cluster headache (cCH) vs. healthy controls (HCs))