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Идёт набор NCT07502612

Evaluation of Medication Tapering on the Sensitivity of the Spinal Cord Using Closed-Loop Spinal Cord Stimulation (Pilot Study)

— Наблюдательное Failed Back Surgery Syndrome (FBSS) Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine Neurophysiological Sensitivity to Spinal Cord Stimulation

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: Spinal Cord Stimulation with Evoke Closed-Loop System.
Кому может быть актуально
Состояния в реестре: Failed Back Surgery Syndrome (FBSS), Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Neurophysiological Sensitivity to Spinal Cord Stimulation. 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
Бельгия
Следующий шаг
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Официальное название

Neurophysiological Effects of Pain Medication Reduction During Treatment With Closed-Loop Spinal Cord Stimulation: A Pilot Study

Обзор

This pilot study investigates the effects of reducing pain medication including opioids and anticonvulsants, on spinal cord sensitivity during closed-loop spinal cord stimulation (SCS). Patients with Persistent Spinal Pain Syndrome Type 2 (FBSS/FNSS) will undergo a standard 21-day SCS trial with the Evoke closed-loop system, followed by permanent implantation if successful. Neurophysiological responses (activation plots, conduction velocity, chronaxie, rheobase) and patient-reported outcomes (VAS, activity, sleep, medication intake) will be collected during the trial and up to 6 months after implantation. The goal is to evaluate the relationship between medication tapering and spinal cord sensitivity

Подробное описание

This is a single-centre, open-label, prospective pilot study in Belgium. Twenty patients scheduled for SCS with the Evoke ECAP-controlled closed-loop system will be enrolled. Eligible patients must use at least one qualifying pain medication at a minimum daily dose (gabapentin ≥150 mg, pregabalin ≥75 mg, morphine ≥40 mg, hydromorphone ≥10 mg, oxycodone ≥20 mg, fentanyl ≥25 µg).

The study includes baseline assessments, a 3-week trial period, permanent implantation if successful, and follow-up visits at 1, 3, and 6 months. Data collected include VAS pain, sleep, activity, medication use, and neurophysiological parameters (activation plots, conduction velocity, chronaxie, rheobase).

The primary endpoint is the effect of medication reduction on spinal cord sensitivity to SCS. Secondary endpoints include changes in pain intensity, medication use, sleep, activity, and additional neurophysiological outcomes.

Вмешательства

  • Другое Spinal Cord Stimulation with Evoke Closed-Loop System
    All patients undergo a 21-day trial with Evoke closed-loop SCS. If successful, patients receive a permanent implant. Assessments include activation plots, conduction velocity, chronaxie, rheobase, VAS pain, sleep, activity, and medication intake.

Первичные конечные точки

  • Spinal cord sensitivity expressed in ECAP amplitude (µV) as a function of the SCS stimulation amplitude (mA). [Срок оценки: From start of SCS trial (baseline) to 6 month after permanent implantation.]
Вторичные конечные точки (4)
  • Change in pain intensity measured using a 10 cm Visual Analog Scale (VAS) [Срок оценки: From start of SCS trial (baseline) to 6 month after permanent implantation.]
  • Change in pain medication intake measured via Belgian Pain Platform (BPP) and clinical verification [Срок оценки: From start of SCS trial (baseline) to 6 month after permanent implantation.]
  • Change in neurophysiological parameters such as conduction velocity (m/sec), rheobase (mA) and chronaxie (µs), measured using the Evoke system's neurophysiological assessment tools. [Срок оценки: From start of SCS trial (baseline) to 6 month after permanent implantation.]
  • Changes in sleep and activity scores [Срок оценки: From start of SCS trial (baseline) to 6 month after permanent implantation]

Критерии участия

Критерии включения

  • Candidate for SCS and scheduled for trial with Evoke system.
  • Diagnosis of FBSS or FNSS (PSPS-T2).
  • Current use of ≥1 qualifying pain medication at or above minimum daily dose:
  • Gabapentin ≥150 mg
  • Pregabalin ≥75 mg
  • Morphine ≥40 mg
  • Hydromorphone ≥10 mg
  • Oxycodone ≥20 mg
  • Fentanyl ≥25 µg
  • Signed informed consent.
  • Age ≥18 years.

Критерии исключения

  • Active disruptive psychiatric disorder or condition impacting pain perception or compliance.
  • Progressive neurological disease (MS, CIDP, progressive arachnoiditis, progressive diabetic neuropathy, brain/spinal tumor, severe spinal stenosis).
  • Coagulation disorder, platelet dysfunction, progressive vascular disease, or uncontrolled diabetes with procedural risk.
  • Active systemic or local infection.
  • Pregnancy.
  • Significant untreated addiction or substance abuse (within 6 months prior)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Бельгия · 1 центр
  • Brai²n - ZAS Augustinus — Wilrijk

Идентификаторы

NCT: NCT07502612 · GZA-ECAP-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗