NCT05183087

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Male
• Age: 25 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Traumatic Brain Injury
• Blast Injuries

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	3T Connectome MRI	MRI scan of structural connectivity
DIAGNOSTIC_TEST	7 Tesla MRI	MRI scan of functional connectivity
DIAGNOSTIC_TEST	TSPO PET	PET scan of neuroinflammation
DIAGNOSTIC_TEST	Tau PET	PET scan of tau deposition
DIAGNOSTIC_TEST	Cognitive and Behavioral Assessments	Assessments of memory, attention, complex reasoning, mood and other cognitive/behavioral domains
DIAGNOSTIC_TEST	Blood Biomarkers	Blood-based assessments of proteomic and metabolic biomarkers of brain injury

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2022-01-10
• Last updated: 2023-04-04

Locations

1 site across 1 country: United States