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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-14

Study Completion Date

2029-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Blast Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This diagnostic study of a single group - active-duty United States Navy SEALs -will utilize PBR28 TSPO PET. Use of the PBR tracer is overseen by the U.S. FDA. Thus, this study is considered "interventional". However, given that the purpose of the study is to develop an initial diagnostic testing protocol for repeated blast brain injury, the typical Phase criteria for therapeutic trials do not apply here. We have selected "Phase 2" from the required list of choices, because the safety of the PRB tracer has been previously established (hence Phase 1 is not appropriate) and because this is not a definitive efficacy study (hence Phase 3 is not appropriate).

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

The investigators analyzing the MRI, cognitive, psychological, physical symptom, and exposure data will be blinded to the PRB28 TSPO PET results. Similarly, the investigators analyzing the PBR28 TSPO PET results will be blinded to all other data elements. The participants will be also be blinded to PBR28 TSPO PET results.

Study Groups

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Active-duty United States Navy SEALs

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

Group Type EXPERIMENTAL

PBR28 TSPO PET

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No