Cerebrovascular Reactivity Assessed With Functional Near-infrared Spectroscopy and Magnetic Resonance Imaging as a Biomarker of Traumatic Microvascular Injury in American Football Players
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Effect of single dose sildenafil citrate treatment on global blood oxygen level-dependent (BOLD) response to hypercapnia.
研究概览
简要总结
Investigators will measure cerebrovascular reactivity (CVR) using functional near-infrared spectroscopy (fNIRS) and magnetic resonance imaging (MRI) during the chronic phase after repetitive mild traumatic brain injury (rmTBI) as a biomarker of traumatic cerebrovascular injury (TCVI). We hypothesize that CVR will be decreased in patients with rmTBI and that these decreases will correlate with clinical outcomes. Furthermore, we predict that 5 week administration of a phosphodiesterase 5 (PDE5) inhibitor, sildenafil citrate, will augment CVR in patients with a history rmTBI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 40-65 years
- •Former National Football League (NFL) players or former varsity college football players
- •Ability to undergo MRI scanning
- •Ability to read, write, and speak English
- •Stable doses of concomitant medications for last 2 weeks prior to enrollment
- •Diagnosis of post-concussive syndrome according to Diagnostic and Statistical Manual 5 (DSM-5) criteria
排除标准
- •Contraindication to sildenafil
- •Past medical history or evidence of penetrating brain injury
- •Daily therapy with a PDE5 inhibitor within the past 2 months, or taken as needed within past 4 weeks
- •History or evidence of pre-existing disabling neurological or psychiatric disorder not related to previous head injuries
- •History of melanoma
- •History of diagnosed obstructive/ restrictive pulmonary disease 7 .) Contraindication to MRI
研究组 & 干预措施
Sildenafil Citrate
Open label treatment with forced titration of sildenafil citrate.
干预措施: Sildenafil Citrate (Drug)
结局指标
主要结局
Effect of single dose sildenafil citrate treatment on global blood oxygen level-dependent (BOLD) response to hypercapnia.
时间窗: Immediate
Determine if single dose treatment with sildenafil (60 mg orally) is effective in increasing the global BOLD response to hypercapnia (5% CO2).
次要结局
- Effect of single dose sildenafil citrate treatment on functional near-infrared spectroscopy (fNIRS) response to hypercapnia.(Immediate)
- Maximum tolerable dose of sildenafil therapy without severe adverse events.(5 weeks)
研究者
Ramon Diaz-Arrastia
Presidential Professor
University of Pennsylvania