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Long-Term Effects of Repetitive, Low-Level Blast Exposure on Special Operations Forces Service Members — ReBlast  

Traumatic Brain Injury Clinical Trial

Official title:
Pilot Study of Long-Term Effects of Repetitive, Low-Level Blast Exposure (RLLBE) on Special Operations Forces (SOF) Service Members

Clinical Trial 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.

Clinical Trial Description

The proposal includes a comprehensive battery of assessments characterized by high-field neuroimaging, proteomics, and experimental cognitive and neurobehavioral evaluations, which will be implemented alongside standardized clinical diagnostic tools. The results will inform the design of a larger trial to validate the diagnostic utility of these biomarkers as well as their ability to predict RLLBE-related clinical outcomes. A secondary aim will be to define the underlying mechanisms, risk and resilience factors, and clinical phenotypes associated with RLLBE. Biomarkers assessed over the course of a two-day evaluation will include: 1. 3 Tesla Connectome MRI to detect structural disruption of brain networks 2. 7 Tesla MRI to detect functional disruption of brain networks 3. Translocator protein (TSPO) PET - ligand [11C]-PBR28 to detect neuroinflammation 4. Tau PET - ligand [18F]-MK6240 to detect tau deposition 5. Neurocognitive assessments to detect signs of cognitive/behavioral dysfunction 6. Self-report indicators of cognitive/behavioral dysfunction 7. Blood biomarkers to detect evidence of blast injury using proteomics and metabolomics We hypothesize that a multimodal assessment using Connectome MRI, 7 Tesla MRI, TSPO PET, Tau PET, cognitive/behavioral tests, proteomics and metabolomics will identify biomarkers of RLLBE-related brain injury. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05183087
Study type Observational
Source Massachusetts General Hospital
Contact
Status Completed
Phase
Start date July 1, 2021
Completion date February 28, 2023
View Details
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