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 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT03502967
Eligibility Criteria:
Inclusion Criteria:
TBI Patients
* Injury occurred within 30 days
* Documented and verified TBI by Glascow coma scal 10-15 and/or Loss of Consciousness \>10 minutes.
* Head Computed Tomography at admission.
ALL Subjects:
* 18 through 60 years of age.
* Ability to understand the the willingness to sign a writteninformed consent.
* All races and ethnicities will be included; subjects must be able to read and speak either the English or Spanish language.
Exclusion Criteria:
* Non-traumatic structural brain abnormality identified on head CT.
* Metallic foreign bodies on the scalp or cranium which may interfere with MRI acquisitions.
* Penetrating TBI.
* Significant anatomic distortion of the brain identified on CT images, such as large hematomas, herniation, intraventricular hemorrhage, extensive subarachnoid hemorrhage, hydrocephalus.
* Significant polytrauma that would interfere with follow-up and outcome assessment.
* Patients on psychiatric hold.
* Major debilitating mental health disorders including, but not limited to schizophrenia and bipolar disorder that would limit compliance with study requirements.
* Major debilitating neurological disease including, but not limited to, stroke, CVA, dementia and tumor that would limit compliance with study requirements.
* Under influence of illicit drugs which are known to alter brain physiology/metabolism including, but not limited to cocaine, lysergic acid diethylamide (LSD), and marijuana at the time of MRI/MRSI scanning.
* Any contraindication per MRI Screening Form including
* Implants contraindicated at 3T, pacemakers
* Implantable Cardioverter Defibrillator (ICD)
* Claustrophobia
* Prisoners or patients in custody.
* Medically unstable including
* Heart failure
* Severe left ventricular outflow tract (LVOT) obstruction
* Unstable angina
* Pregnancy
* Lactating
* Subjects who are receiving any other investigational agents.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03502967
Study Brief:
Protocol Section:
NCT03502967