International Headache Registry Study
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: Headache Disorders, Primary, Headache Disorders, Secondary, Migraine, Tension-Type Headache. Базовые параметры: 4 лет — 99 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
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
International Headache and Vertigo Registration Study
Обзор
In the International Headache and Vertigo Registration Study, patients aged 4-99 years with headache (primary headache and secondary headache such as migraine and tension type headache), vertigo (vertigo diseases such as vestibular migraine) and chronic pain (fibromyalgia and other diseases) were collected. The biomarkers, imaging features, right-to-left shunt of the heart (lung), genetic characteristics, treatment, and outcome (in relation to other diseases) of headache-related diseases were studied, and long-term follow-up was planned.
Подробное описание
1. Research contents:
In the International Headache and Vertigo Registration Study, patients aged 4-99 years with headache (primary headache and secondary headache such as migraine and tension type headache), vertigo (vertigo diseases such as vestibular migraine) and chronic pain (fibromyalgia and other diseases) were collected. The biomarkers, imaging features, right-to-left shunt of the heart (lung), genetic characteristics, treatment, and outcome (in relation to other diseases) of headache-related diseases were studied, and long-term follow-up was planned. 2. Research target:
We study biomarkers, imaging features, right-to-left shunt of heart (lung), genetic features, real-world treatment studies, and outcomes (in relation to other diseases) for headache and vertigo related diseases.
Первичные конечные точки
- Days of Migraine [Срок оценки: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Moderate / Severe Headache Days [Срок оценки: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Migraine Attack [Срок оценки: Medium term: within 6 months after initial diagnosis; long term: 60 years]
Вторичные конечные точки (12)
- The Response Rate of at Least 50%, 75% and 100% Reduction in the Number of Days of Migraine Attacks [Срок оценки: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Headache Intensity [Срок оценки: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Cumulative Hours of Moderate / Severe Pain at 28 Days [Срок оценки: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Days Without Symptoms [Срок оценки: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Days Without Headache [Срок оценки: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Peak Headache Pain Intensity [Срок оценки: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Migraine Disability Assessment (MIDAS) [Срок оценки: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Headache Impact Scale (HIT-6) [Срок оценки: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Migraine Specific Quality of Life Questionnaire (MSQV2.1) [Срок оценки: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Patient Health Questionnaire (PHQ-9) [Срок оценки: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Generalized Anxiety Disorder (GAD-7) [Срок оценки: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Functional Impairment Scale (FIS) [Срок оценки: Medium term: within 6 months after initial diagnosis; long term: 60 years]
Критерии участия
Критерии включения
The following are requirements for entry into the study:
- Written informed consent and participant privacy information (eg, Written Authorization for Use and Release of Health and Research Study Information) obtained from the participant prior to initiation of any study-specific procedures.
- Male or female participants ages 4 to 99 years, inclusive, at Visit 1.
- Headache patients meeting the diagnostic criteria for ICHD-3, including primary headaches such as migraine and tension tension-type headaches, secondary headaches, and patients who meet the headache diagnosis in the ICHD-3 appendix (including vestibular migraine).
Критерии исключения
- Patients who were unable to complete scales such as headache diary.
- Patients denied or unable to be admitted for long-term follow-up.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Kaiming Liu — Ханчжоу
Идентификаторы
NCT: NCT05418218 · 20220430