Long-Term Effects of Repetitive, Low-Level Blast Exposure on Special Operations Forces Service Members
ReBlast
Pilot Study of Long-Term Effects of Repetitive, Low-Level Blast Exposure (RLLBE) on Special Operations Forces (SOF) Service Members
1 other identifier
observational
30
1 country
1
Brief Summary
This is a pilot study to identify biomarkers that individually, and in combination, demonstrate the greatest sensitivity to repetitive, low-level blast exposure (RLLBE) neurotrauma in Special Operations Forces (SOF) personnel. The proposed cross-sectional, multimodal study will elucidate the potential effects of long-term RLLBE by comparing biomarkers across subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
December 9, 2021
CompletedFirst Posted
Study publicly available on registry
January 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedApril 4, 2023
April 1, 2023
1.7 years
December 9, 2021
April 3, 2023
Conditions
Outcome Measures
Primary Outcomes (8)
Diffusion MRI structural connectivity
measured by white matter tractography
Day 1
fMRI resting state functional connectivity
measured by default mode network connectivity
Day 2
PET Neuroinflammation
measured by standardized uptake value ratio of TSPO ligand \[11C\]PBR28
Day 1
PET Tau deposition
measured by standardized uptake value ratio of \[18F\]MK6240
Day 2
Neurofilament Light Chain
measured by serum concentration of neurofilament light chain
Day 1, after 6-8 hour fasting
Cognitive Function
measured by the Trail Making Test
Day 1
Behavioral symptoms
measured by the Neurobehavioral Symptom Inventory
Day 2
Physical symptoms
measured by the Neurobehavioral Symptom Inventory
Day 2
Study Arms (1)
Special Operations Forces (SOF) Personnel
n=30 SOF Personnel
Interventions
MRI scan of structural connectivity
MRI scan of functional connectivity
Assessments of memory, attention, complex reasoning, mood and other cognitive/behavioral domains
Blood-based assessments of proteomic and metabolic biomarkers of brain injury
Eligibility Criteria
U.S. Special Operations Forces personnel
You may qualify if:
- Adults aged 25-45 years of age
- Males, regardless of race or ethnicity
- Active duty Special Operation Forces
- History of combat deployment confirmed by Veterans Affairs (VA) or Department of Defense (DOD) records (defined as: while serving in the U.S. military, individual was deployed to a region of conflict)
- History of combat exposure during any deployment as measured by endorsement of any item on the Combat Exposure Scale (CES)
You may not qualify if:
- History of moderate or severe traumatic brain injury (TBI) (using the VA/DOD definition: initial Glasgow Coma Scale score \< 13, coma duration \> ½ hr, post-traumatic amnesia duration \> 24 hr, or abnormal structural brain imaging)
- History of major neurologic disorder such as stroke or spinal cord injury resulting in a significant decrement in functional status or loss of independent living capacity
- Untreated or unstable severe psychiatric condition (e.g., schizophrenia or bipolar disorder) that is likely to impact study participation or ability to complete study procedures
- Current severe medical condition (excluding currently diagnosed mild TBI or concussion) that requires long-term treatments (e.g., cancer, diabetes mellitus, human immunodeficiency virus, autoimmune disorders)
- Any cardiac, respiratory, or other medical condition that may affect cerebral metabolism
- Benzodiazepines other than lorazepam, desmethyldiazepam and oxazepam within past month
- MRI contraindications
- Metal in the body that would make an MRI scan unsafe, such as pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye
- Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
- Inability to lie supine for up to 2 hours in the MRI scanner, as assessed by physical examination and medical history (e.g., back pain, arthritis)
- \> 300 lbs (weight limit of the MRI table)
- Prior radiation exposure of ≥ 50 mSv over the past 12 months, in the context of research, as determined by review of DOD medical records (e.g., prior imaging studies) and self-report
- Any condition which, in the opinion of the Principal Investigator, may cause undue risk to the subject
- Other: Any condition or characteristic that in the judgment of the Principal Investigator would create a logistical or safety contraindication to enrollment (e.g., shoulder width greater than the bore of the MRI or PET/MRI machines)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian L Edlow, M.D.
Massachusetts General Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neurocritical Care Faculty and Associate Professor of Neurology
Study Record Dates
First Submitted
December 9, 2021
First Posted
January 10, 2022
Study Start
July 1, 2021
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
April 4, 2023
Record last verified: 2023-04