Brain Single Photon Emission Computed Tomography and Quantitative Electroencephalography In Former NFL Players: A Single-Site Exploratory Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- A concentration SPECT scan will be given to assess the changes in regional cerebral blood flow to the brain in our study participants.
研究概览
简要总结
The investigators primary objective is to acquire preliminary data on one-hundred former NFL veterans with at least one full year of professional service using brain SPECT imaging in order to assess the degree to which NFL football puts players at risk for traumatic brain injury (TBI). TBI severity shall be gauged via visual inspection by a clinician trained in neuroanatomy, and also by a statistical comparison of subjects' brains to an in-house proprietary database comprised of the brains of healthy subjects.
The investigators secondary objective is to acquire additional data on these players such that investigators may establish causative factors and risks associated with said TBI.
The investigators tertiary objective is to acquire data on subjects using various mental health metrics in order to determine the effects of TBI.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects must be at least 18 years of age
- •Each subject must have been on an active NFL roster for a minimum of one year
排除标准
- •Any subjects who could not cease taking psychoactive medications (recreational or otherwise) for an appropriate washout period prior to scanning were excluded from the study
结局指标
主要结局
A concentration SPECT scan will be given to assess the changes in regional cerebral blood flow to the brain in our study participants.
时间窗: The SPECT scan is one day imaging exam. A follow up scan will be performed following a 2-12 month supplement intervention.
For the concentration study the subject will start the Conner's Continuous Performance Task, a 15-minute computer-administered test of attention, subsequent to the accommodation period. Three minutes into task performance 20 milliCuries of Tc-99m-hexamethylpropylene amine oxime will be injected through the catheter with attention to minimal disruption of the subject's attention task. The subject will proceed to completion of the attention task. The concentration scans will then be compared to a healthy brain subject normative database.
次要结局
- Quantitative electroencephalography (QEEG) will be used to assess the damage to neural networks in our study participants.(The QEEG testing is one day exam. A follow up test will be performed following a 2-12 month supplement intervention.)