Metformin in Preventing Secondary Gliosis Following Acute Thoraco-Lumbar Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metformin, Placebo.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injury (SCI). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety and Efficacy of Metformin in Preventing Secondary Gliosis Following Acute Thoraco-Lumbar Spinal Cord Injury: A Randomized, Double-Blinded, Placebo-Controlled Study.
Overview
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
Detailed description
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.
Interventions
- Drug Metformin
Participants assigned to the metformin group will receive 1,000 mg of immediate-release metformin orally, twice daily - Drug Placebo
Participants in the placebo group will receive an identical-appearing placebo, administered orally, twice daily
Primary outcome measures
- Neurological recovery [Time frame: 2 weeks, and 3-months postoperatively.]
Secondary outcome measures (2)
- Pain intensity [Time frame: at 2 weeks, and 3-months postoperatively]
- Neuropathic Pain character [Time frame: at 2 weeks, and 3-months postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Neurosurgery department at Menoufia University hospitals at Menoufia University. — Shibīn al Kawm
Identifiers
NCT: NCT07272967 · 9/2025NEUS6