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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT04044456
Eligibility Criteria:
Inclusion Criteria:
Veterans with a diagnosis mTBI between the ages of 18 to 55, that demonstrate a deficit in attention, pass effort testing and have not changed psychotropic medication within the past two weeks.
* all Veterans who have served in OIF-OEF-OND with single- (at least brief loss of conscious) or multiple (with at least alteration of consciousness) mild traumatic brain injury (mTBI) during deployment, who seek services at North Florida/South Georgia Veterans Health System (NF-VHS).
* TBI must have suffered their injury at least 6 months prior to study enrollment and currently be in stable neurological condition.
* age range 19-55 years to reduce the impact of aging on treatment improvement.
* Attention deficit of 1.5 SD below the mean of the RBANS attention index. This will ensure that participants have an objective deficit attention.
* Family member or friend that is willing to complete the BRIEF-A (BRIEF-A guidelines of face to face interaction with the participant at least twice a week) at all measurement time points.
* 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 either the Test of Memory Malingering (TOMM),). Score of 45 or less on TOMM Trial 2 or retention trial.
* Reported alcohol or substance abuse within the past year
* Reported involvement in current litigation
* 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.
* Psychotropic drugs that have changed within the past two-weeks that would impact performance during assessment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT04044456
Study Brief:
Protocol Section:
NCT04044456