Not Yet RecruitingPhase 4

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

Egypt34 participantsStarted 2026-01-01

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

Neurological recovery

Timeframe: 2 weeks, and 3-months postoperatively.

Trial details

NCT IDNCT07272967

SponsorBadr University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-01

Contact for this trial

Eman Swan, PHD

+201090111013 eman.said@buc.edu.eg