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Идёт набор NCT07325058

Tonic Pain and Transauricular Vagal Nerve Stimulation

Без фазы С лечением Experimental Pain in Healthy Human Subjects

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: taVNS, Earlobe Stimulation, Sham (No Treatment).
Кому может быть актуально
Состояния в реестре: Experimental Pain in Healthy Human Subjects. Базовые параметры: 16 лет — 60 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
Дания
Следующий шаг
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Официальное название

Exploration of the Effect, and Their Duration, of Different Frequency Transcutaneous Auricular Vagal Nerve Stimulation on Sensory Perception.

Обзор

This study aims to explore the effect of burst-taVNS (electric stimulation of the concha cymba) on tonic (capsaicin-induced skin pain) and acute (pressure pain sensitivity) experimental pain and cardioception. Primary outcomes include pain intensity. Secondary outcomes include sensory thresholds, resting heart rate (EKG), pupillary measurements and conditioned pain modulation.

Подробное описание

Across 3 visits, each lasting around 2.5hours, burst-taVNS (electrical stimulation of the concha cymba) will be compared to active-control (electrircal stimulation of the earlobe) and sham (no current) stimulation, two gold-standard controls. Assessments of outcomes will occur before capsaicin application and before, twice during and after electrical ear stimulation.

Вмешательства

  • Устройство taVNS
    Two-headed ball-point electrode which is placed in the concha cymba.
  • Устройство Earlobe Stimulation
    Circular urface adhering electrodes will be attached to either facet of the earlobe.
  • Устройство Sham (No Treatment)
    Circular surface adhesive electrodes will be placed on either facet of the earlobe. No current will pass through the electrodes.

Первичные конечные точки

  • Pain Intensity [Срок оценки: From when capsaicin is applied to the end of the experiment in 5 min intervals.]
Вторичные конечные точки (6)
  • Pressure Pain Detection Threshold [Срок оценки: Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).]
  • Conditioned Pain Modulation Effect [Срок оценки: Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).]
  • Pressure Pain Perception [Срок оценки: Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).]
  • Pupillary Light Reflex [Срок оценки: Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).]
  • Electrocardiography [Срок оценки: Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).]
  • Cardioception Accuracy [Срок оценки: Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).]

Критерии участия

Критерии включения

  • Healthy
  • Speak and understand English
  • 18-60 years old.

Критерии исключения

  • Pregnant and/or breastfeeding
  • Regular use of cannabis, opioids or other drugs
  • Current or previous neurologic, musculoskeletal, mental, or other illnesses (e.g., brain or spinal cord injuries, degenerative neurological disorders, major depression, cardiovascular disease, chronic lung disease, etc.)
  • Current regular (once or more a week) use of analgesic medication or other medication which may affect the trial (including paracetamol and NSAIDs)
  • Recent history of acute pain particularly in the lower limbs
  • Abnormally disrupted sleep in 24 hours preceding experiment
  • Contraindications to electric stimulation application (history of epilepsy, metal implants in head or jaw, etc.)
  • Lack of ability to cooperate
  • Contraindications for capsaicin including an intolerance chili consumption and burns or wounds to the application site.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Тройное слепое
Основная цель
Фундаментальное исследование

Центры проведения

Дания · 1 центр
  • Center For Neuroplasticity and Pain — Aalborg

Идентификаторы

NCT: NCT07325058 · N-20230022-5

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗