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 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT05380050
Eligibility Criteria:
Inclusion Criteria:
* Veterans who have served in OIF-OEF-OND and have been diagnosed with both a mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) based on the joint criteria of the Veterans' Affairs and Department of Defense (VA \& DoD).
* Latest mTBI occurred at least 6 months prior to study enrollment.
* Attention deficit of 1.5 SD below the mean of the RBANS attention index.
* Family member or friend that is willing to complete a questionnaire.
* Access to a home computer, or smartphone with internet access.
Exclusion Criteria:
* History of pre-morbid learning disability.
* History of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization.
* Neurological disease unrelated to TBI (seizure disorder, stroke).
* Score \< 90 on National Adult Reading Test (NART).
* Failure of validity testing on the Test of Memory Malingering (TOMM).
* Reported alcohol or substance abuse within the past year.
* Reported involvement in current litigation related to injury.
* Recent change of medications for seizures, depression, or memory.
* Currently enrolled in other cognitive therapy that cannot be discontinued.
* Does not speak English fluently.
* Not competent to provide consent (also, not able to demonstrate understanding of expectations of study and potential risks of participation).
* Uncontrolled, acute medical or psychiatric condition as indicated by the participant or observed by the research team member that would make it unsafe to participate in the research activities, i.e. precautions for active homicidal/suicidal intent, active psychosis, or acute symptoms requiring immediate medical attention.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
55 Years
Study:
NCT05380050
Study Brief:
Protocol Section:
NCT05380050