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Идёт набор NCT06443281

Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury

— Наблюдательное Spinal Cord Injuries Pain, Neuropathic Nociceptive Pain Neuropathy

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: Neurophysiology, Cardiovascular test, Experimental pain paradigms, Quantitative sensory testing.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injuries, Pain, Neuropathic, Nociceptive Pain, Neuropathy. 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
Швейцария
Следующий шаг
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Обзор

The development of neuropathic pain is one of the most debilitating sequels after a spinal cord injury (SCI). The overall aim of this study is to investigate potential underlying pathophysiological mechanisms of neuropathic pain after SCI. The functionality of the nociceptive pathway in humans as well as its plastic changes following SCI will be inferred with sophisticated sensory and pain phenotyping using quantitative sensory testing (i.e., psychophysical measures), objective neurophysiological measures of pain processing and the recording of pain-related autonomic responses (i.e., galvanic skin response, cardiovascular measures and pupil dilation). In addition, the interplay between the somatosensory and autonomic nervous system and its association with the development and maintenance of neuropathic pain after SCI will be investigated.

Вмешательства

  • Диагностический тест Neurophysiology
    Pain-related evoked potentials and nerve conduction studies
  • Диагностический тест Cardiovascular test
    Blood pressure control, orthostatic intolerance test, baro-reflex sensitivity, heart-rate variability
  • Диагностический тест Experimental pain paradigms
    Temporal summation of pain, conditioned pain modulation, offset analgesia
  • Диагностический тест Quantitative sensory testing
    Thermal and mechanical sensory testing
  • Диагностический тест Clinical pain phenotype
    Pain drawings, plus and minus signs of pain
  • Диагностический тест Pupillometry
    Pupil size changes after phasic and tonic sensory stimulation

Первичные конечные точки

  • Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity [Срок оценки: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity [Срок оценки: Cross-sectional: once in a chronic stage (1 year post-injury)]
  • Patients with peripheral neuropathy: clinical pain phenotype including the spatial pain extent and pain intensity [Срок оценки: Cross-sectional: once in a chronic stage (1 year post-injury)]
Вторичные конечные точки (12)
  • Spinal cord injury patients / healthy controls: somato-sensory evoked potentials [Срок оценки: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: somato-sensory evoked potentials [Срок оценки: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: contact-heat evoked potentials [Срок оценки: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: contact-heat evoked potentials [Срок оценки: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: N13 spinal potential [Срок оценки: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: N13 spinal potential [Срок оценки: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: motor neurographies [Срок оценки: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: motor neurographies [Срок оценки: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: motor neurographies [Срок оценки: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: sensory neurography [Срок оценки: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: sensory neurography [Срок оценки: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: sensory neurography [Срок оценки: Longitudinal: change from 1 month up to 12 months]

Критерии участия

Критерии включения

  • Spinal injury cohort - general inclusion criteria:
  • Aged between 18-80 years
  • Traumatic and non-traumatic etiology
  • Para- and tetraplegic SCI
  • Complete and incomplete SCI
  • SCI with and without neuropathic pain
  • Additional inclusion criteria for longitudinal study:
  • SCI since less than one month
  • Additional inclusion criteria for cross-sectional study:
  • SCI since more than one year
  • Control cohorts with peripheral neuropathy:
  • General inclusion criteria:
  • Aged between 18-80 years
  • Neurological disorder affecting the peripheral nervous system (i.e., peripheral neuropathy)
  • Peripheral neuropathy with or without neuropathic pain
  • Additional inclusion criteria for longitudinal study:
  • Peripheral neuropathy since less than one month
  • Additional inclusion criteria for cross-sectional study:
  • Peripheral neuropathy since more than one year
  • Control cohorts without neuropathy / healthy volunteers
  • General inclusion criteria:
  • Aged between 18-80 years
  • No medical condition affecting the peripheral and/or central nervous system (e.g., pain, systemic disease, psychological disorder)

Критерии исключения

  • Inability to follow study instructions
  • Pregnancy
  • Medically manifested psychological disorder
  • Medical condition affecting the peripheral and/or central nervous system other than the desired experimental condition (e.g., additional peripheral neuropathy in the SCI cohort)

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 1 центр
  • Balgrist University Hospital — Zurich

Идентификаторы

NCT: NCT06443281 · 2024-00134

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗