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| ID | Type | Description | Link |
|---|---|---|---|
| H9240525FE002 | Other Grant/Funding Number | United States Department of Defense |
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| Name | Class |
|---|---|
| University of South Florida | OTHER |
| Navy SEAL Foundation | UNKNOWN |
| National Institutes of Health (NIH) | NIH |
| Uniformed Services University of the Health Sciences |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active-duty United States Navy SEALs | Experimental | All SEAL participants will undergo comprehensive, longitudinal assessments of their exposures, cognitive performance, psychological health, physical symptoms, neuroimaging biomarkers, and blood biomarkers. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| neuroimaging biomarkers | 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 | 1 year |
| blood biomarkers | tau, ptau, bd-tau, NF-L, GFAP, UCH-L1, IL-6, IL-10, TNF alpha | 1 year |
| neuropsychiatric symptoms | Neurobehavioral Symptom Inventory | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian L Edlow, M.D. | Contact | 617-724-6352 | bedlow@mgh.harvard.edu | |
| Michael A Gordon, B.s. | Contact | 617-724-6352 | magordon@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38648470 | Background | 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 Special Operations Forces. Proc Natl Acad Sci U S A. 2024 May 7;121(19):e2313568121. doi: 10.1073/pnas.2313568121. Epub 2024 Apr 22. |
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USSOCOM regulations prevent public release of the data generated for the current study. Future requests for these data may be submitted to the corresponding author and will then need to be vetted by USSOCOM.
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| ID | Term |
|---|---|
| D001753 | Blast Injuries |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001469 | Barotrauma |
| D014947 | Wounds and Injuries |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
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| FED |
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).
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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.
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |