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
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.
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.
Parallel
Metformin
DrugParticipants assigned to the metformin group will receive 1,000 mg of immediate-release metformin orally, twice daily
Placebo
DrugParticipants in the placebo group will receive an identical-appearing placebo, administered orally, twice daily
Neurological recovery
Comparison of postoperative American Spinal Injury Association (ASIA) Impairment Scale grade ranging from A to E where Grade A= Complete spinal cord injury and Grade E=Normal function
Pain intensity
Comparison of postoperative patient-reported pain using Visual Analog Scale (VAS) that is ranging from 0-10 score where 0=no pain and10= the worst possible pain
Neuropathic Pain character
Comparison of postoperative Neuropathic character of pain using Neuropathic Pain Symptom Inventory (NPSI) scale ranging from 0-10 score where 0=no pain and 10= the worst possible pain
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