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Идёт набор NCT06459635

Migraine Attack Pain Phase Prediction Study

— Наблюдательное Migraine Migraine Headache Migraine Disorders Migraine Without Aura

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Migraine, Migraine Headache, Migraine Disorders, Migraine Without Aura. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
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Официальное название

Prediction Study of the Pain Phase of Migraine Attacks in Patients With Episodic Migraine

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Development of a prediction strategy for the onset of migraine [Срок оценки: From the beginning of treatment, which is the initial visit, to 2 months of follow-up]
Вторичные конечные точки (3)
  • Posibility of predict the onset of pain in a migraine attack [Срок оценки: From the beginning of treatment, which is the initial visit, to 2 months of follow-up]
  • Individualized prediction algorithm [Срок оценки: From the beginning of treatment, which is the initial visit, to 2 months of follow-up]
  • Effectiveness of the prediction model [Срок оценки: From the beginning of treatment, which is the initial visit, to 2 months of follow-up]

Критерии участия

Критерии включения

  • Age between 15 years and 69 years.
  • Diagnosed with migraine by a headache neurologist and according to the criteria proposed by ICHD-3.
  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Испания · 1 центр
  • Hospital Universitario de La Princesa — Madrid

Публикации

  • Gago-Veiga AB, Pagan J, Henares K, Heredia P, Gonzalez-Garcia N, De Orbe MI, Ayala JL, Sobrado M, Vivancos J. To what extent are patients with migraine able to predict attacks? J Pain Res. 2018 Sep 27;11:2083-2094. doi: 10.2147/JPR.S175602. eCollection 2018. PMID 30310310
  • Pagan J, De Orbe MI, Gago A, Sobrado M, Risco-Martin JL, Mora JV, Moya JM, Ayala JL. Robust and Accurate Modeling Approaches for Migraine Per-Patient Prediction from Ambulatory Data. Sensors (Basel). 2015 Jun 30;15(7):15419-42. doi: 10.3390/s150715419. PMID 26134103

Идентификаторы

NCT: NCT06459635 · 3513

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗