Precision Biomarkers to Detect Brain Injury in Active-Duty United States Special Operations Forces With Repeated Blast Exposure

Mass General Brigham

Status and phase: Enrolling; Phase 2

Conditions: Blast Injury

Treatments: Drug: PBR28 TSPO PET

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT07131475

H9240525FE002 (Other Grant/Funding Number)

2025P000608

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Active-duty United States Navy SEALs

Experimental group

Description:

All SEAL participants will undergo comprehensive, longitudinal assessments of their exposures, cognitive performance, psychological health, physical symptoms, neuroimaging biomarkers, and blood biomarkers.

Treatment:

Drug: PBR28 TSPO PET