Набор по приглашению NCT07553533

Utilization of 60-Day Peripheral Nerve Stimulation of the Occipital Nerves for the Treatment of Headache

— Наблюдательное Headache

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: В протоколе указаны: Occipital nerve peripheral nerve stimulation (PNS).
Кому может быть актуально: Состояния в реестре: Headache. Базовые параметры: от 18 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: США
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

Utilization of 60-Day Peripheral Nerve Stimulation of the Occipital Nerves for the Treatment of Headache: A Prospective Multisite Cohort Study of Health Care Resource Utilization and Clinical Outcomes

Обзор

This prospective observational cohort study will evaluate clinical outcomes and health care resource utilization among adults who, independent of research participation, are clinically scheduled to undergo temporary 60-day occipital nerve peripheral nerve stimulation (PNS) as part of routine care for refractory headache disorders.

Подробное описание

The main purpose of this prospective observational cohort study is to evaluate clinical outcomes and health care resource utilization among adults who, independent of research participation, are clinically scheduled to undergo temporary 60-day occipital nerve peripheral nerve stimulation (PNS) as part of routine care for refractory headache disorders.

The study will assess changes in headache impact, pain intensity, neck-related disability, patient global impression of change, medication utilization, and headache-related health care utilization over 12 months. The anticipated impact of this research is improved understanding of whether occipital PNS delivered in standard clinical practice is associated with better patient-reported outcomes, fewer acute care visits, and lower utilization of health system resources, which may ultimately inform clinical decision-making, quality-of-life improvement, and potential cost savings.

Planned analyses include within-subject longitudinal comparisons from baseline to 60 days and 12 months, site adjusted modeling of utilization outcomes, and exploratory analyses of predictors of response across headache diagnoses and patient subgroups.

Вмешательства

Процедура Occipital nerve peripheral nerve stimulation (PNS)
Temporary 60-day occipital nerve PNS as part of routine care.

Первичные конечные точки

Change in headache impact [Срок оценки: 60 days]
Change in health care resource utilization (HCRU) [Срок оценки: 12 months]

Вторичные конечные точки (9)

Change in numeric rating scale [Срок оценки: 12 months]
Change in neck disability index [Срок оценки: 12 months]
Change in global impression of change [Срок оценки: 12 months]
IMMPACT ≥30% pain reduction [Срок оценки: 12 months]
IMMPACT Pain Relief ≥50% [Срок оценки: 60 days]
IMMPACT Pain Relief ≥80% [Срок оценки: 60 days]
IMMPACT Pain Relief ≥50% [Срок оценки: 12 months]
Medication utilization [Срок оценки: 12 months]
Healthcare Utilization [Срок оценки: 12 months]

Критерии участия

Критерии включения

Diagnosis of a headache disorder for which the treating clinician has independently made the clinical decision to proceed with temporary 60-day occipital nerve PNS as part of routine care, including:
Occipital neuralgia
Chronic migraine
Chronic tension-type headache
Chronic cluster headache
Cervicogenic headache
Clinically scheduled to undergo temporary 60-day occipital PNS as part of routine care.
Ability to provide informed consent.