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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT00754169
Eligibility Criteria:
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TBI PATIENTS:
We will study up to 320 head-injured IA warfighters (200 PHI and 120 blast injuries), most of whom have served in Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), and up to 500 who have been included in the VHIS Registry. PHI makes up about 20% of the total TBI from OIF and OEF.
We will ask all WHIS patients to travel to the NIH with their primary caregiver to serve as their Durable Power of Attorney (DPA) (see Section X for more information on the DPA); Caregivers will be asked to complete questionnaires and will execute a separate consent (see Caregiver Consent Form).
Inclusion of active duty military personnel is not essential to this study and can be completed without them, if necessary.
INCLUSION:
* Both sexes will be included, however we expect the cohort to be overwhelmingly (\>90%) male,
* Age range18-75;
* At least 6 months post-head injury; or
* Those patients who have previously participated in the VHIS.
EXCLUSION:
-Any medical condition that, in the judgment of investigators, would make participation detrimental to the patient (e.g.: severe clinical depression, unstable heart disease).
CONTROLS:
We will recruit 50 of the VHIS controls, 200 healthy IA warfighter control subjects, with no history of neurologic or serious psychiatric disorder or any other medical condition that would pose a risk from participation (e.g., unstable heart disease) and 120 healthy volunteers with different exposures but no documentation of brain injury. An example of this latter group would include someone who might be employed as a teacher of the proper use of explosive devices (i.e. a trainer from the Bureau of Alcohol, Tobacco and Firearms) and functions well in that position except for an occasional complaint. We will recruit up to a total of 370 normal volunteers.
We will ask all WHIS controls to travel to the NIH with a companion, some one deemed close to them in terms of relationship (i.e.spouse, child, etc.), to serve as control participants for the caregivers of warfighters. Companions will be asked to complete questionnaires and will execute a separate consent (see Caregiver/Companion Consent Form).
INCLUSION:
* Control subjects will be healthy IA warfighter volunteers who are matched to head-injured IA warfighters for time in service, combat exposure, age, gender and preinjury ASVAB scores. All IA warfighter control participants must provide copies of their ASVAB induction testing scores, if applicable; or
* Individuals who have had different blast exposures (e.g., explosives expert) but no documentation of brain injury; or
* Those warfighter controls who have previously participated in the VHIS.
EXCLUSION:
* Neurological or psychiatric conditions as mentioned above;
* History of drug abuse; or
* Unable to travel independently.
CAREGIVERS/COMPANIONS:
We will enroll caregivers and companions (i.e.: family members, domestic partners, etc.) of WHIS Warfighter participants in order to learn more about the potential burden and related issues experienced by this group.
INCLUSION:
* Provides care to a Warfighter or,
* Chosen by a control participant as a close companion; and
* Their Warfighter provides informed consent and agrees to participate in the WHIS project.
EXCLUSION:
* Inability to provide informed consent; or
* No working knowledge of the English language.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00754169
Study Brief:
Protocol Section:
NCT00754169