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 @ 1:53 PM
Ignite Modification Date:
2025-12-24 @ 1:53 PM
NCT ID:
NCT04262895
Eligibility Criteria:
Inclusion Criteria:
* Veteran receiving care at the VA San Diego Healthcare system
* age 18-65
* history of mild to moderate TBI (loss of consciousness \<24 hours; posttraumatic amnesia \<7 days)
* documented impairment (\>1 standard deviation below the mean) in at least one neuropsychological domain as determined by valid clinical neuropsychological testing using at least one performance validity test, i.e.:
* attention
* processing speed
* working memory
* learning, memory
* executive functioning
* DSM-5 diagnosis of PTSD based on the Clinician-Administered PTSD Scale
Exclusion Criteria:
* current alcohol and/or substance abuse or dependence
* high risk for homicide or suicide
* evidence of a significant uncontrolled/unstable medical illness or clinically significant surgery
* laboratory values that are significantly outside normal limits
* history of intolerance or hypersensitivity to cysteamine or penicillamine
* current participation in other intervention studies
* pregnant or intending to become pregnant in the next 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04262895
Study Brief:
Protocol Section:
NCT04262895