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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT03379220
Eligibility Criteria:
Inclusion Criteria:
1. Enrollment in TRACK-TBI CA cohort
2. Admission to intensive care
3. Documented TBI \<24 hr before anticipated placement of electrodes
4. Lobe of primary injury accessible for ECoG by burr hole or craniotomy access
5. Age ≥ 18 years
6. Acute brain CT for clinical care
7. Visual acuity/hearing adequate for testing
8. Fluency in English or Spanish
9. Ability to obtain informed consent
Exclusion Criteria:
1. Significant polytrauma that would confound outcome assessment
2. Prisoners or patients in custody
3. Pregnancy
4. Patients on psychiatric hold
5. Major debilitating baseline mental health disorder that would interfere with follow-up and the validity of outcome
6. Major debilitating neurological disease impairing baseline awareness, cognition, or validity of follow-up and outcome assessment
7. Significant history of pre-existing conditions that would interfere with follow-up and outcome assessment
8. Low likelihood of follow-up
9. Current participation in an interventional trial
10. Penetrating TBI
11. Spinal cord injury with ASIA score of C or worse
12. Bilateral unreactive pupils or other evidence of unsurvivable injury
13. Evidence of coagulopathy (INR\>1.5 or thrombocytopenia) or infection, which contraindicate invasive monitoring
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03379220
Study Brief:
Protocol Section:
NCT03379220