Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT07272967
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07272967
Study Brief:
Protocol Section:
NCT07272967