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 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT03191357
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, at least 18 years of age.
2. Active duty, retired military SM, TRICARE eligible reservist or National Guardsman, or a family member eligible for care in the DoD healthcare system.
3. Ability to provide self-consent
4. For TBI participants, must report having symptoms or diagnosis of a concussion, TBI with or without loss of consciousness, or PCS; the duration of time since the head injury will be documented, but there is no limitation on duration since some CNRM studies do not place a time limit. Medical documentation is preferred but not required
5. For participants with psychological health concerns, must report having current symptoms or may already have a diagnosis of PTSD, depression, or generalized anxiety disorder.
6. For injured participants without TBI, must be (i) exposed to primary blast or (ii) have other orthopedic and/or soft-tissue injury for which they sought care at a medical treatment facility within the past six months. Injury sustained can be combat or non-combat related.
7. For healthy controls, must be healthy with no prior diagnosis of TBI, concussion, PTSD, and/or other PH issues, and no history of exposure to blast.
8. Are willing to have their contact information and data shared and stored by the CNRM for referral to current and future CNRM studies.
Exclusion Criteria:
1. Individuals who are unable to provide their own informed consent for the study
2. Individuals who are unwilling or unable to cooperate with study procedures
3. Individuals with penetrating brain injury with residual shrapnel or other MRI-incompatible metal embedded in the brain or skull (excluded from MRI only, can still take part in study)
4. Individuals with contraindication to MRI scanning including certain metal implants or devices (excluded from MRI only, can still take part in study)
5. Those with conditions precluding entry or prolonged durations in the MRI scanners, e.g. morbid obesity, severe claustrophobia, etc., (excluded from MRI only, can still take part in study)
6. Pregnancy: urine pregnancy tests will be performed on all females prior to the conduct of MRI; if a positive pregnancy test is identified, MRI will not be performed, can still take part in study.
7. Individuals with self reported psychosis, schizophrenia, schizoaffective disorder, bipolar disorder, conversion disorder or personality disorder.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03191357
Study Brief:
Protocol Section:
NCT03191357