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NCT Number: NCT07131475

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

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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Key information

Conditions

Blast Injury Barotrauma Blast Injuries Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Brian L Edlow, MD

CONTACT

[email protected]

617-724-6352

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Active-duty Navy SEAL Service Member
  • Early career SEAL (0-2 years) or mid-late career SEAL (10-15 years)
  • Age 18-50 years
  • Males, regardless of race or ethnicity

Exclusion criteria

  • History of moderate or severe TBI
  • History of major neurological disorder
  • Untreated or unstable severe psychiatric condition
  • Current severe medical condition that requires long-term treatment
  • Any condition that may cause undue risk to the participant or create a logistical contraindication
  • MRI contraindication
  • PET contraindication

Treatment and study plan

PBR28 TSPO PET

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.

Primary outcomes

  1. neuroimaging biomarkers

    Time frame: 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

  2. blood biomarkers

    Time frame: 1 year

    tau, ptau, bd-tau, NF-L, GFAP, UCH-L1, IL-6, IL-10, TNF alpha

  3. neuropsychiatric symptoms

    Time frame: 1 year

    Neurobehavioral Symptom Inventory

Study contacts

Contact information is provided by the study sponsor or research team.

Brian L Edlow, M.D.

CONTACT

[email protected]

617-724-6352

Michael A Gordon, B.s.

CONTACT

[email protected]

617-724-6352

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institutes of Health (NIH)
  • Navy SEAL Foundation
  • Uniformed Services University of the Health Sciences
  • University of South Florida

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 20, 2025
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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