Long-Term Effects of Repetitive, Low-Level Blast Exposure on Special Operations Forces Service Me… (NCT05183087) | Clinical Trial Compass
CompletedNot Applicable
Long-Term Effects of Repetitive, Low-Level Blast Exposure on Special Operations Forces Service Members
United States30 participantsStarted 2021-07-01
Plain-language summary
This is a pilot study to identify biomarkers that individually, and in combination, demonstrate the greatest sensitivity to repetitive, low-level blast exposure (RLLBE) neurotrauma in Special Operations Forces (SOF) personnel. The proposed cross-sectional, multimodal study will elucidate the potential effects of long-term RLLBE by comparing biomarkers across subjects.
Who can participate
Age range25 Years – 45 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adults aged 25-45 years of age
✓. Males, regardless of race or ethnicity
✓. Active duty Special Operation Forces
✓. History of combat deployment confirmed by Veterans Affairs (VA) or Department of Defense (DOD) records (defined as: while serving in the U.S. military, individual was deployed to a region of conflict)
✓. History of combat exposure during any deployment as measured by endorsement of any item on the Combat Exposure Scale (CES)
Exclusion criteria
✕. History of moderate or severe traumatic brain injury (TBI) (using the VA/DOD definition: initial Glasgow Coma Scale score \< 13, coma duration \> ½ hr, post-traumatic amnesia duration \> 24 hr, or abnormal structural brain imaging)
✕. History of major neurologic disorder such as stroke or spinal cord injury resulting in a significant decrement in functional status or loss of independent living capacity
✕. Untreated or unstable severe psychiatric condition (e.g., schizophrenia or bipolar disorder) that is likely to impact study participation or ability to complete study procedures
✕. Current severe medical condition (excluding currently diagnosed mild TBI or concussion) that requires long-term treatments (e.g., cancer, diabetes mellitus, human immunodeficiency virus, autoimmune disorders)
✕. Any cardiac, respiratory, or other medical condition that may affect cerebral metabolism
. Benzodiazepines other than lorazepam, desmethyldiazepam and oxazepam within past month
✕. MRI contraindications
✕. Metal in the body that would make an MRI scan unsafe, such as pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye