Recruiting
Phase 2

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT07131475

Conditions

Blast Injury

Eligibility Criteria

Sex: Male

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

PBR28 TSPO PET

Study Details

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.

Conditions

Blast Injury

Study ID

NCT07131475

Start date

Oct 14, 2025

Status verified date

Oct, 2025

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • neuroimaging biomarkers [ Time Frame: 1 year ]
  • blood biomarkers [ Time Frame: 1 year ]
  • neuropsychiatric symptoms [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Brian L Edlow, M.D.

617-724-6352bedlow@mgh.harvard.edu

Michael A Gordon, B.s.

617-724-6352magordon@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Brian L Edlow, MD

617-724-6352bedlow@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

  • repeated blast exposure
  • Special Operations Forces
  • traumatic brain injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-10-31.