The Effects of Subconcussive Events on Cognition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in cognition secondary to impact
研究概览
简要总结
The purpose of this study is to determine early detection of concussion for those at risk of developing symptoms and to be able to detect subconcussive cerebral impairment, and thus gaining a better understanding of the injury patterns for concussions in Men's and Women's Collegiate sports.
详细描述
Description of the Research Subjects will be members of NYIT's Collegiate Athletic Teams. Potential subjects will be informed about the proposed study and asked if the athlete is interested in participating. If the athlete agrees, the key investigator will review the study procedures, what is expected of the subject, and complete the informed consent process. Participation will be completely voluntary and will have no impact on the quality of care the subject will receive. Inclusion and exclusion criteria will then be evaluated by the key investigator to determine if the subject is qualified to participate in this study. Following consent and review of inclusion and exclusion criteria, the subject will be assigned a subject identification number in which is intended to maintain confidentiality of the subject's personal health information. The number will be used for the duration of the study and in all analyses. Once enrolled, the subjects will complete a baseline questionnaire* that will include demographic information and personal history, as well as consent for de-identified information to be shared with a third party, Quadrant Biosciences, for research purposes. The subjects will be evaluated by a series of measurements, ClearEdge, Quadrant Bioscience Salivary Testing, King Devick, and Im PACT, in the preseason, midseason, and postseason, or if they are suspected of a concussion by the athletic trainer or team physician. Visit 1: Baseline Data Collection
- Assessment Tools
- Demographic/Baseline questionnaire*
- ImPACT
- King-Devick
- ClearEdge New York Institute of Technology Institutional Review Board Approved From 07/18/20 to 07/17/21
- Quadrant Bioscience Salivary Testing
- Quadrant Bioscience Salivary Testing Questionnaire
- Estimated Time: 1.5 hours Visit 2: Mid-Season Collection
- Assessment Tools
- ImPACT
- King-Devick
- ClearEdge
- Quadrant Bioscience Salivary Testing
- Quadrant Bioscience Salivary Testing Questionnaire
- Estimated time: 1 hour Visit 3: Post-season Data Collection
- Assessment Tools
- ImPACT
- King-Devick
- ClearEdge
- Quadrant Bioscience Salivary Testing
- Quadrant Bioscience Salivary Testing Questionnaire
- Estimated time: 1 hr Visit 4: If athlete is suspected to have sustained a concussion by the athletic trainer or team physician, the athlete will come for an additional visit
- Assessment Tools
- ImPACT
- King-Devick
- ClearEdge
- Quadrant Bioscience Salivary Testing
- Quadrant Bioscience Salivary Testing Questionnaire
- Estimated time: 1 hr
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Subject is at least 18 years age and younger than 50 years of age
- Subject experiences at least 8Gs of force on at least one occasion, as measured by accelerometer
排除标准
- The subject suffered from any of the following at the time of event leading to a concussion:
- Loss of consciousness >2 minutes in the field as reported by witness
- Seizures
- Intractable vomiting
- Paralysis
- The subject has been diagnosed with an underlying neurodegenerative condition that may confound test results (e.g. Parkinson's Disease, Alzheimer's Disease)
- The subject has a current or previous spinal cord injury
- The subject is unable to complete assessment tools
- The subject is pregnant
结局指标
主要结局
Changes in cognition secondary to impact
时间窗: 5 months
A mouthguard with built in sensors to collect data above the predetermined acceleration thresholds. The predetermined threshold for acceleration will be set to 5G in order to collect more data about subconcussive impacts, in addition to concussive impacts
次要结局
- C3 Logix(5 months)
- ImPACT Testing(5 months)
- King-Devick Test(5 months)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT03394248
- 其他研究编号
- BHS-1304
日期
- 首次提交
- (8年前)
- 首次发布
- (8年前)
- 主要完成日期
- (8年前)
- 研究完成日期
- (6年前)
- 最近核实
- 最近更新
- (4年前)
监管与共享
- FDA 监管药物
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否
May share with osteopathic medical research students