Prospective, Observational Study to Assess Migraine Prediction Tool Based on Prodromal Symptoms and Additional Parameters
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Validation of an effective algorithm and software to predict migraine attacks.
研究概览
简要总结
This is a prospective, observational study. The participant will be required to approve his/her participation in the study by completing the electronic consent form. Data collected within the first eight weeks (weeks 1-8) will be used to develop the prediction models (either personal or population/group models). The developed algorithm will be freezer and tested against the data collected during weeks 1-8 of a different cohort population
详细描述
Migraine treatment may be acute (abortive) or preventive (prophylactic), with patients often requiring both. The objectives of acute treatment are to treat attacks early; to achieve quick pain relief; to minimize or eliminate adverse events; to restore function; to decrease recurrence and the need for rescue treatment; and to reduce medical resource use. Preventive treatment is aimed to lower the frequency, intensity, and duration of the attacks.
In general, a prodrome is an early sign or symptom (or set of signs and symptoms) that often indicates the onset of a disease before more diagnostically specific signs and symptoms develop. Prodromal or premonitory symptoms occur in about 60% of those with migraines, with an onset that can range from two hours to two days before the start of pain or the aura. These symptoms may include a wide variety of phenomena including altered mood, irritability, depression or euphoria, fatigue, craving for certain food(s), stiff muscles (especially in the neck), constipation or diarrhea, and sensitivity to smells or noise. This may occur in those with either migraine with aura or migraine without aura. Neuroimaging indicates the limbic system and hypothalamus as the origin of prodromal symptoms in migraine.
Robust prediction of migraine attacks could lead to pre-emptive treatment, provide patients with opportunities to plan for impending attacks, reduce interictal anxiety, and improve self-efficacy among other benefits.
This study aims to develop and evaluate the effectiveness of a migraine prediction tool based on early prodromal (pre-migraine) symptoms, that may enhance the acute treatment of migraine
Prior enrollment, Informed consent must be obtained from each participant before any protocol-related activities are performed. Participants will receive a daily notification (through an app notification) with a link to the daily questionnaire. The app may collect other data items, related to the specific location of every participant, such as weather, air quality, etc.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Subject age 18-75 years.
- •Subject has migraine diagnosis for over 6 months prior to enrolling to the study.
- •Subject has 4-24 headache days per month.
- •Subject has a Nerivio user account, or willing to create a Nerivio user account to participate in the study.
- •Subject is willing to sign an Informed Consent Form.
排除标准
- 未提供
结局指标
主要结局
Validation of an effective algorithm and software to predict migraine attacks.
时间窗: Predication period of 24 hours prior headache
The primary endpoint will be the Predivio's prediction model sensitivity and specificity, presented by receiver operating characteristic (ROC) analysis using the Area Under the Curve (AUC) within the validation cohort population
次要结局
- Predivio's percent of participants for whom the sensitivity and specificity are at least 80%.(Predication period of 24 hours prior headache)
- Predivio accuracy(Predication period of 24 hours prior headache)