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 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT03241732
Eligibility Criteria:
Inclusion Criteria:
* Individuals with a history of TBI and complaints of persistent symptoms including cognitive impairment, emotional disturbances, headache, or other symptoms associated with TBI
* Age 18-80 years old
* Patients had no other pre-existing history (i.e. prior to the TBI) of significant medical, neurological, or psychological disorders such as schizophrenia or active substance abuse.
* Minor, stable health problems that should have no substantial effect on cerebral blood flow will be allowed (i.e. controlled hypertension, medication controlled diabetes)
* Able to give informed consent and willing to complete the study
* Patients will be allowed to be taking medications or supplements at the initial intake, but they must be on a stable dose regimen for at least 1 month
* Women of childbearing potential will confirm a negative pregnancy test NET Substudy: Anxiety and/or distress associated with TBI or TBI symptoms by measurement with Subjective Units of Distress, and biofeedback screening
Exclusion Criteria:
* Previous brain surgery.
* Cognitive impairment with significant impact on activities of daily living and/or a score on the Mini-Mental Status examination (or similar) of 25 or lower
* Intracranial abnormalities that may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality affecting the target area).
* Pregnant or lactating women.
* Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
* Any pre-existing medical conditions that may interfere with cerebral function.
* Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia or weight \> 350 pounds)
* Subject has metal in their body or other reason that they cannot undergo magnetic resonance imaging.
Additional exclusionary criteria for the NAC arm:
* Patients taking medications that might interact with the NAC involved in this study will be evaluated on a case by case basis by the PI or study physician.
* Patients that have a history of uncontrolled conditions, e.g.: diabetes, asthma, gastroesophageal reflex disease, or thyroid conditions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03241732
Study Brief:
Protocol Section:
NCT03241732