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

Not Applicable

Not yet recruiting

• Conditions: Blast Injury
• Interventions: Drug: PBR28 TSPO PET

• Registration Number: NCT07131475
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2025-07-24
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Study Start: 2025-09-04
• Primary Completion: 2029-04-30
• Study Completion: 2029-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active-duty United States Navy SEALs	PBR28 TSPO PET	All SEAL participants will undergo comprehensive, longitudinal assessments of their exposures, cognitive performance, psychological health, physical symptoms, neuroimaging biomarkers, and blood biomarkers.

Primary Outcome Measures

Name	Time	Method
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