Blast Injury
Conditions
Keywords
repeated blast exposure, Special Operations Forces, traumatic brain injury
Brief summary
This is a 4-year, longitudinal study of 100 active-duty Navy SEALs. The goal of the study is to determine whether repeated blast exposure affects SEAL brain health and to develop an initial diagnostic testing protocol that detects repeated blast brain injury.
Detailed description
Participants will travel to Massachusetts General Hospital (MGH) in Boston, MA for a 1-day study visit at enrollment (baseline) and 1-year follow-up. At each visit to MGH, participants will have brain scans, blood tests, and assessments of cognitive performance, psychological health, and physical symptoms. Every 3 months between the baseline and follow-up visits to Boston, there will be brief (\ 1 hour) assessments via phone or video teleconference.
Interventions
DRUGPBR28 TSPO PET
Each SEAL participant will undergo brain imaging with PBR28 translocator protein (TSPO) positron emission tomography (PET) at study enrollment and at 1-year follow up.
Sponsors
University of South Florida
Navy SEAL Foundation
National Institutes of Health (NIH)
Uniformed Services University of the Health Sciences
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The investigators analyzing the MRI, cognitive, psychological, physical symptom, and exposure data will be blinded to the PRB28 TSPO PET results. Similarly, the investigators analyzing the PBR28 TSPO PET results will be blinded to all other data elements. The participants will be also be blinded to PBR28 TSPO PET results.
Intervention model description
This diagnostic study of a single group - active-duty United States Navy SEALs -will utilize PBR28 TSPO PET. Use of the PBR tracer is overseen by the U.S. FDA. Thus, this study is considered interventional. However, given that the purpose of the study is to develop an initial diagnostic testing protocol for repeated blast brain injury, the typical Phase criteria for therapeutic trials do not apply here. We have selected Phase 2 from the required list of choices, because the safety of the PRB tracer has been previously established (hence Phase 1 is not appropriate) and because this is not a definitive efficacy study (hence Phase 3 is not appropriate).
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Active-duty Navy SEAL Service Member 2. Early career SEAL (0-2 years) or mid-late career SEAL (10-15 years) 3. Age 18-50 years 4. Males, regardless of race or ethnicity
Exclusion criteria
1. History of moderate or severe TBI 2. History of major neurological disorder 3. Untreated or unstable severe psychiatric condition 4. Current severe medical condition that requires long-term treatment 5. Any condition that may cause undue risk to the participant or create a logistical contraindication 6. MRI contraindication 7. PET contraindication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| neuroimaging biomarkers | 1 year | TSPO tracer uptake within the brain on TSPO PET, functional connectivity of the executive control, default and salience networks on resting-state functional MRI and diffusion MRI, and brain signal abnormalities on multidimensional MRI |
| blood biomarkers | 1 year | tau, ptau, bd-tau, NF-L, GFAP, UCH-L1, IL-6, IL-10, TNF alpha |
| neuropsychiatric symptoms | 1 year | Neurobehavioral Symptom Inventory |
Countries
United States
Contacts
Primary ContactBrian L Edlow, M.D.
Backup ContactMichael A Gordon, B.s.
Outcome results
None listed