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

NCT07131475 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-31

No results posted yet for this study

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.

Conditions

  • Blast Injury

Interventions

DRUG

PBR28 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 & Collaborators

  • University of South Florida

    collaborator OTHER

  • Navy SEAL Foundation

    collaborator UNKNOWN

  • National Institutes of Health (NIH)

    collaborator NIH

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2029-04-30
Completion
2029-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07131475 on ClinicalTrials.gov