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:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-24 @ 5:16 PM
NCT ID:
NCT02878850
Eligibility Criteria:
Inclusion Criteria:
1. Acute traumatic spinal cord injury (SCI) involving neurological levels as defined by the ASIA neurological examination between C0 and T8 (tetraplegia) and resulting in new onset neurological deficits consistent with an ASIA motor assessment of level A, B or C.
2. Subject is 18 years of age or older.
Exclusion Criteria:
1. Penetrating SCI injury.
2. Isolated cauda equina syndrome or injury at bony level Th9 or below.
3. Pre-existing motor deficit secondary to chronic myelopathy.
4. History of demyelinating disease or central nervous system autoimmune disorder.
5. History within the past six months and/or physical findings on admission of decompensated congestive heart failure (NYHA functional class III or IV, or objective class C or D).
6. Acute, evolving or recent (30 days) myocardial infarction.
7. Chronic renal failure requiring dialysis.
8. Suspected or confirmed pregnancy.
9. Severe terminal disease with life expectancy less than 6 months.
10. Severe traumatic brain injury at presentation (GCS ≤8) with confirmation of injury on brain imaging.
11. A condition that would preclude the performance of an accurate neurological exam due to a prior diagnosis of Alzheimer's disease, stroke, degenerative condition, cerebral tumor, or mental retardation.
12. Non-English or Non-Spanish Speaking.
13. Refusal of consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02878850
Study Brief:
Protocol Section:
NCT02878850