NCT07131475 Precision Biomarkers to Detect Brain Injury in Active-Duty United States Special Operations Forces With Repeated Blast Exposure
| NCT ID | NCT07131475 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Blast Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-10-14 |
| Primary Completion | 2029-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-10-14 with a primary completion date of 2029-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07131475 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 50 Years, studying Blast Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07131475 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07131475 currently recruiting?
Yes, NCT07131475 is actively recruiting participants. Contact the research team at bedlow@mgh.harvard.edu for enrollment information.
Where is the NCT07131475 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07131475 clinical trial?
NCT07131475 is sponsored by Massachusetts General Hospital. The trial plans to enroll 100 participants.