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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT05725993
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-65, inclusive
2. History of non-penetrating TBI of at least moderate severity (defined by evidence of trauma-related neuroimaging abnormality on cranial computerized tomography (CT) scan.
3. High-velocity, high-impact injury mechanism consistent with diffuse axonal injury (e.g., motor vehicle accident, fall from height, etc.)
4. Immediate loss of consciousness (cases with delayed loss of consciousness due to expanding lesions will be excluded)
Exclusion Criteria:
1. History of premorbid disabling neurological or psychiatric disease (such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, HIV-encephalitis)
2. History of premorbid disability condition that would interfere with outcome assessments
3. Bilaterally absent pupillary Reponses
4. Penetrating TBI
5. Elevated intracranial pressure (≥ 17 mmHg) 6 Contradictions to contrast-enhanced MRI (e.g., ferromagnetic implants, pregnancy, allergy to gadolinium contrast, renal impairment \[GFR \< 60ml/g/m3\], claustrophobia, hemodynamic instability)
7\. Prisoners, patients in police custody 8. Objective lung disease (PaCO2 at rest \> 50 mmHg or venous serum bicarbonate \> 26 mEg/L) based on any labs available for review from patient's clinical care. Note that these will not be checked solely for study purposes 9.Requiring portable oxygen at enrollment 10. Chronic heart failure, severe pulmonary disease 11. Current substance abuse that precludes participation and follow-up in the study, as determined by the study investigators 12. If there is medical or other disability that precludes completion of the study procedures as determined by the study investigators
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05725993
Study Brief:
Protocol Section:
NCT05725993