Prediction Study of the Pain Phase of Migraine Attacks in Patients With Episodic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Development of a prediction strategy for the onset of migraine
研究概览
简要总结
The study of the ability to predict pain in a migraine attack, through premonitory symptoms and through an ambulatory monitoring device through real-time recording of hemodynamic variables, is one of the strategic lines of research of the unit. of Headaches at the Hospital de La Princesa since 2013 together with the Complutense and Polytechnic University of Madrid. Their results have been reflected in various publications (Pagán J, et al. Sensors 2015; Gago-Veiga AB, et al. J Pain Res 2018) and have promoted the creation of several invention patents.
详细描述
Patients with episodic migraine will be recruited from the monographic headache clinics of the 7 centers participating in the study. These patients, for a maximum period of 2 months, must monitor their hemodynamic variables with a wearable device and record all the clinical characteristics of their migraine attacks. Subsequently, with these records, an individualized algorithm will be created for each patient that aims to predict the onset of the migraine attack.
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
- •Age between 15 years and 69 years.
- •Diagnosed with migraine by a headache neurologist and according to the criteria proposed by ICHD-
- •History of migraine of at least 1 year of evolution.
- •Normal neurological examination.
- •Have given your informed consent.
- •Be able to describe your clinical situation and the characteristics of your headache.
- •Have an average of 10 to 14 migraine days per month in the three months prior to inclusion (high-frequency episodic migraine).
- •User-level management capacity of "smartphone" type electronic devices.
- •Be able to complete two months of study follow-up.
排除标准
- •Presence of another type of headache, with the exception of headache due to excessive use of analgesic medication.
- •Cognitive deficiency or any other pathology that may prevent or make it difficult for the patient to perform the study correctly.
- •Neurological focus in the examination.
- •Pregnancy or breastfeeding period.
- •Patients with known heart disease or bronchopathy, Sjögren's syndrome, diabetes mellitus, or hypo/hyperthyroidism.
- •Carriers of pacemakers, neurostimulators or any other electronic device that is considered to make the interpretation of biometric records difficult.
- •Anatomical problem that makes the use of the device impossible.
- •Patients in whom it is expected that a change in migraine preventive treatment or other usual treatment will be possible during the study period.
结局指标
主要结局
Development of a prediction strategy for the onset of migraine
时间窗: From the beginning of treatment, which is the initial visit, to 2 months of follow-up
Develop a prediction strategy for the onset of migraine attacks in patients with episodic migraine, based on hemodynamic and clinical variables of migraine attacks.
次要结局
- Effectiveness of the prediction model(From the beginning of treatment, which is the initial visit, to 2 months of follow-up)
- Posibility of predict the onset of pain in a migraine attack(From the beginning of treatment, which is the initial visit, to 2 months of follow-up)
- Individualized prediction algorithm(From the beginning of treatment, which is the initial visit, to 2 months of follow-up)
研究者
Ana Gago
Head of the Headache Unit
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa