ReBlast Precision (Precision Biomarkers to Detect Brain Injury in Active-Duty United States Special Operations Forces With Repeated Blast Exposure)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- neuroimaging biomarkers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active-duty United States Navy SEALs
All SEAL participants will undergo comprehensive, longitudinal assessments of their exposures, cognitive performance, psychological health, physical symptoms, neuroimaging biomarkers, and blood biomarkers.
干预措施: PBR28 TSPO PET (Drug)
结局指标
主要结局
neuroimaging biomarkers
时间窗: 1 year
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
blood biomarkers
时间窗: 1 year
tau, ptau, bd-tau, NF-L, GFAP, UCH-L1, IL-6, IL-10, TNF alpha
neuropsychiatric symptoms
时间窗: 1 year
Neurobehavioral Symptom Inventory
次要结局
未报告次要终点
研究者
Brian L. Edlow, M.D.
Principal Investigator
Massachusetts General Hospital