Metformin in Preventing Secondary Gliosis Following Acute Thoraco-Lumbar Spinal Cord Injury (NCT07272967) | Clinical Trial Compass
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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.