Precision Biomarkers to Detect Brain Injury in Active-Duty United States Special Operations Forces With Repeated Blast Exposure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PBR28 TSPO PET.
- Who it may be relevant to
- Registry conditions: Blast Injury. Basic parameters: 18 years — 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ReBlast Precision (Precision Biomarkers to Detect Brain Injury in Active-Duty United States Special Operations Forces With Repeated Blast Exposure)
Overview
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.
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.
Primary outcome measures
- neuroimaging biomarkers [Time frame: 1 year]
- blood biomarkers [Time frame: 1 year]
- neuropsychiatric symptoms [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Publications
- Gilmore N, Tseng CJ, Maffei C, Tromly SL, Deary KB, McKinney IR, Kelemen JN, Healy BC, Hu CG, Ramos-Llorden G, Masood M, Cali RJ, Guo J, Belanger HG, Yao EF, Baxter T, Fischl B, Foulkes AS, Polimeni JR, Rosen BR, Perl DP, Hooker JM, Zurcher NR, Huang SY, Kimberly WT, Greve DN, Mac Donald CL, Dams-O'Connor K, Bodien YG, Edlow BL. Impact of repeated blast exposure on active-duty United States Specia PMID 38648470
Identifiers
NCT: NCT07131475 · 2025P000608 · H9240525FE002