Меню
Набор скоро начнётся NCT07272967

Metformin in Preventing Secondary Gliosis Following Acute Thoraco-Lumbar Spinal Cord Injury

Фаза IV С лечением Spinal Cord Injury (SCI)

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: Metformin, Placebo.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injury (SCI). Базовые параметры: 18 лет — 65 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
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Safety and Efficacy of Metformin in Preventing Secondary Gliosis Following Acute Thoraco-Lumbar Spinal Cord Injury: A Randomized, Double-Blinded, Placebo-Controlled Study.

Обзор

Background: Spinal cord injury (SCI) is a major global health problem, with thoraco-lumbar injuries often leading to paraplegia and incomplete neurological recovery. The glial scar, resulting from astrocyte activation at the injury site, constitutes a major barrier to axon regeneration. Given the limitations of current treatments, there is an urgent need for new interventions to improve outcomes. Metformin, a common drug for diabetes, shows promising potential as a neuroprotective agent in preclinical SCI models, where it improves motor function and reduces pain and glial scar formation. Its safety in acute neurological injury has also been supported in a recent human trial for severe traumatic brain injury. Objective: To test the safety and efficacy of metformin in acute thoraco-lumbar SCI, focusing on neurological and functional outcomes as well as DTI metrics of spinal cord integrity. Methods. Study Design. Randomized, double-blinded, placebo-controlled study. Population: Participants that will be admitted during the time of the study to Neurosurgery department at Menoufia University hospitals at Menoufia University. Setting: Neurosurgery department at Menoufia University hospitals at Menoufia University. Keywords: Metformin, spinal cord injury, gliosis, randomized controlled trial, neuroprotection

Подробное описание

Study Design. Randomized, double-blinded, placebo-controlled study. Randomization and Blinding. Participants will be randomly assigned to either the metformin or placebo group in a 1:1 ratio using block randomization. A computer-generated randomization sequence will be created with the R software (version 4.4.1) and the blockrand package(7). This sequence will be securely stored and accessible only to the study statistician. Treatment packets will be pre-labeled with unique numbers matching the randomization sequence. When a patient qualifies for the study, they will receive a numbered packet corresponding to their assignment. To ensure objectivity, neither participants nor study staff will know which number corresponds to metformin or placebo-only the statistician will have access to this information.

Setting:

Neurosurgery department at Menoufia University hospitals at Menoufia University.

Instruments:

We will assess the patient using AISA grade, Visual Analog Scale (VAS) and the Neuropathic Pain Symptom Inventory (NPSI) (8-10).

Data collection:

It will be done by data collaborators under the leadership of the investigators in: Neurosurgery department at Menoufia University hospitals at Menoufia University.

Вмешательства

  • Препарат Metformin
    Participants assigned to the metformin group will receive 1,000 mg of immediate-release metformin orally, twice daily
  • Препарат Placebo
    Participants in the placebo group will receive an identical-appearing placebo, administered orally, twice daily

Первичные конечные точки

  • Neurological recovery [Срок оценки: 2 weeks, and 3-months postoperatively.]
Вторичные конечные точки (2)
  • Pain intensity [Срок оценки: at 2 weeks, and 3-months postoperatively]
  • Neuropathic Pain character [Срок оценки: at 2 weeks, and 3-months postoperatively]

Критерии участия

Критерии включения

  • Adults aged 18-65 years, who had acute, non-penetrating thoraco-lumbar SCI (T1-conus medullaris), with new neurological deficits.
  • Injury occurred within the past 24 hours before enrollment.
  • American Spinal Injury Association (ASIA) Impairment Scale grade B-D.
  • Able to undergo MRI of the spine.
  • Informed consent provided by patient or legal representative.

Критерии исключения

  • Major spinal transaction or cervical spinal cord injury.
  • Prior spinal surgery or pre-existing spinal pathology (e.g., kyphosis, tumors).
  • Concomitant severe traumatic brain injury (Glasgow Coma Scale < 13) or other CNS injury that would confound neurological assessment.
  • Known diabetes mellitus (type 1 or 2) or current use of metformin.
  • Penetrating spinal injury (e.g. gunshot, stab wound).
  • Implanted metallic devices or conditions precluding MRI.
  • Pregnancy or breastfeeding.
  • Severe comorbidities (e.g. end-stage liver disease, renal failure with eGFR<30 mL/min).
  • Known allergy to metformin.
  • Uncontrolled infection or sepsis at presentation.

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

Египет · 1 центр
  • Neurosurgery department at Menoufia University hospitals at Menoufia University. — Shibīn al Kawm

Идентификаторы

NCT: NCT07272967 · 9/2025NEUS6

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗