Detecting brain injury from repeated blast exposure in Navy SEALs
ReBlast Precision (Precision Biomarkers to Detect Brain Injury in Active-Duty United States Special Operations Forces With Repeated Blast Exposure)
This study will test whether blood tests and brain imaging can detect brain injury from repeated blast exposure in active-duty Navy SEALs.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07131475 on ClinicalTrials.gov |
What this trial studies
This is a 4-year longitudinal study enrolling 100 active-duty Navy SEALs to see if repeated blast exposure affects brain health and to develop an initial diagnostic testing protocol. Participants travel to Massachusetts General Hospital in Boston for a one-day baseline visit and a one-day one-year follow-up visit to undergo PBR28 TSPO PET and MRI brain scans, blood biomarker collection, and cognitive, psychological, and physical assessments. Between those visits, participants complete brief (about one hour) remote check-ins every three months to monitor symptoms and exposures. The study enrolls males aged 18–50 in early-career (0–2 years) or mid–late career (10–15 years) SEAL groups and excludes those with prior moderate or severe TBI or major neurological or unstable psychiatric or medical conditions.
Who should consider this trial
Good fit: Ideal candidates are active-duty male Navy SEALs aged 18–50 in early-career (0–2 years) or mid–late career (10–15 years) who have had repeated blast exposure and do not have a history of moderate or severe TBI.
Not a fit: Individuals with prior moderate or severe TBI, major neurological disorders, unstable severe psychiatric or medical conditions, or those who are not active-duty SEALs are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this work could produce an initial diagnostic protocol to detect repeated blast-related brain injury earlier and more objectively, helping guide care for affected service members.
How similar studies have performed: Related studies using TSPO PET and blood biomarkers have shown promise for detecting neuroinflammation after traumatic brain injury, but applying these methods specifically to repeated blast exposure in special operations forces is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Brian L Edlow, M.D.
- Email: bedlow@mgh.harvard.edu
- Phone: 617-724-6352
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.