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Идёт набор NCT07479082

Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Headache Following Stent-Assisted Coiling of Unruptured Intracranial Aneurysms

Без фазы С лечением Unruptured Intracranial Aneurysm Headache Vagus Nerve Stimulations

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: Transcutaneous Auricular Vagus Nerve Stimulation, Sham transcutaneous auricular vagus nerve stimulation.
Кому может быть актуально
Состояния в реестре: Unruptured Intracranial Aneurysm, Headache, Vagus Nerve Stimulations. Базовые параметры: 18 лет — 80 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
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Обзор

The goal of this clinical trial is to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in reducing postoperative headache among adults undergoing stent-assisted coiling for unruptured intracranial aneurysms (UIAs). The study will include male and female participants aged 18 to 80 years who are scheduled for endovascular treatment of UIAs with stent-assisted coiling or flow diverter devices. The main questions it aims to answer are: * Can taVNS reduce the incidence of headache within 90 days after stent-assisted embolization of UIAs? * Is taVNS safe and well-tolerated in this patient population? Researchers will compare patients receiving active taVNS to those receiving sham stimulation to determine if taVNS leads to fewer postoperative headaches and reduced need for analgesic medications. Participants will: * Wear a taVNS device on the left earlobe (active group) or cymba conchae (sham group) starting 1 day before the procedure * Receive 30-minute stimulation sessions, twice daily, until postoperative day 5 * Undergo follow-up assessments of headache occurrence, pain intensity, analgesic use, and any adverse events through day 90 after the procedure

Вмешательства

  • Устройство Transcutaneous Auricular Vagus Nerve Stimulation
    Participants will receive transcutaneous auricular vagus nerve stimulation via a taVNS device applied to the left cymba conchae starting 24 hours before surgery to 5 days after surgery. Stimulation will be administered twice daily, with a 12-hour interval between sessions. Parameters: pulse width of 200-300 µs at 25 Hz and a biphasic pulse interval of 30 s ON and 30 s OFF. The stimulus intensity of the tVNS varied between individuals and is set to the average level, which is defined by the level
  • Устройство Sham transcutaneous auricular vagus nerve stimulation
    Participants will receive transcutaneous auricular vagus nerve stimulation but without electrical current via a taVNS device applied to the left earlobe starting 24 hours before surgery twice daily until postoperative day 5. Stimulation parameters, frequency and duration are identical to the experimental group.

Первичные конечные точки

  • Primary efficacy outcome: Incidence of headache within postoperative day 5 to day 90 [Срок оценки: Postoperative day 5 to day 90]
  • Primary safety outcome: Incidence of taVNS-related adverse events [Срок оценки: From 24 hr before surgery to 5 days after surgery]
  • Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-90 [Срок оценки: Postoperative day 5-90]
Вторичные конечные точки (5)
  • Headache incidence within postoperative day 5-30 [Срок оценки: Postoperative day 5 to day 30]
  • VAS (Visual Analog Scale) scores on postoperative day 30 and 90 [Срок оценки: Postoperative day 30 and 90]
  • Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-30 [Срок оценки: Postoperative day 5-30]
  • Postoperative day 5 levels of blood inflammatory cytokines [Срок оценки: Postoperative day 5]
  • Postoperative day 90 levels of blood inflammatory cytokines [Срок оценки: Postoperative day 90]

Критерии участия

Критерии включения

  • Age 18-80 years
  • Diagnosed with unruptured intracranial aneurysm confirmed by imaging
  • Planned to undergo stent-assisted coiling or flow diverter embolization
  • Signed informed consent

Критерии исключения

  • History of SAH, ICH, brain tumor, major trauma, substance abuse, syncope, or seizures
  • Recurrent/traumatic/infectious/myxomatous aneurysms
  • Primary headache disorders (e.g., migraine, cluster headache, trigeminal neuralgia) not attributed to UIA
  • Previous vagotomy, migraine surgery, or implanted neurostimulators
  • Other concurrent electronic/implantable devices (e.g., pacemakers, neurostimulators)
  • Clinically significant hypotension, congenital heart disease, severe arrhythmia, unstable angina, or recent MI
  • Inability to follow up due to severe psychiatric disorder or refusal
  • Skin lesions at taVNS placement site
  • Pregnant or lactating
  • Participation in other trials

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Capital Medical University Affiliated Beijing Tiantan Hospital — Пекин

Идентификаторы

NCT: NCT07479082 · KY2025-284

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗