Effects of Repetitive Subconcussive Head Impacts on Ocular-motor Function and Brain-derived Blood Biomarker
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Changes in Brain-Derived Blood Biomarker Over Time in Relation to the Baseline
研究概览
简要总结
Repetitive head impacts in sports and military may cause deleterious effects in the nervous system. Investigators' previous works in football players have shown promising results in prediction of concussion and prevention of long-term defect using eye-movement paradigm (ocular-motor system) and blood biomarker. However, acute head impact effects on aforementioned parameters remain unknown. Thus, to answer a critical research question that whether or not ocular-motor system and brain-derived blood biomarker may be acutely altered following 10 successions of controlled soccer heading. To answer the question, investigators hypothesized that acute bout of soccer heading will not elicit noticeable change in subject's symptoms but to induce a transient defect in the ocular-motor system and increase plasma expression of brain-derived biomarker.
详细描述
Adult aged soccer players aged 18-26 years will be recruited via listserv email to Indiana University undergraduate students. Once subjects fulfill inclusion criteria and free of exclusion criteria, participants will be randomly assigned to one of two groups (Heading vs. Kicking).
For non-athletic control cohort, investigators will attempt to recruit 20 subjects who are 18-26 years old, have never played organized sports, and have never been diagnosed with a concussion before. This cohort is to evaluate and account for the soccer players' baseline, which may be influenced by a history of repetitive heading and sports participation. This group will participate in a single test session that lasts approximately in 1.5 hours. During the session, blood draw (4mL, about 1 teaspoon), measure eye movements using an ocular motor headset,
The study consists of 4 data collection time points in a 2-day period. This study design will enable to test outcome measures over 3 acute phases.
- The 1st test session takes place right before the intervention (soccer heading or kicking).
- Participants will perform either soccer heading or kicking.
- The 2nd test session takes place right after the intervention (soccer heading or kicking).
- The 3rd test session takes place 2h after the intervention (soccer heading or kicking).
- The 4th test session takes place approximately 24h after the intervention.
A standardized and reliable soccer heading protocol will be used for the experiment. A triaxial accelerometer (Triax Technologies) embedded in a head-band pocket and positioned back of the head to monitor linear and rotational head accelerations. A JUGS soccer machine will be used to simulate a soccer throw-in with a standardized ball speed of 25mph across both groups. Soccer players frequently perform this maneuver during practice and game. Subjects will stand approximately 40ft away from the machine to perform either the heading or kicking. Participants in the heading group perform 10 standing headers with 1 header per minute, whereas kicking control group performs 10 kicks. The participants in the heading and kicking groups will be instructed to direct the ball back toward the JUGS soccer machine in the air.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Soccer Cohort
- •being between 18 to 26 years of age
- •an active member of a soccer team (i.e., collegiate, intramural, club, professional)
- •at least 5 years of soccer heading experience.
- •For non-Athletic Control Cohort
- •Being between 18 to 26 years of age
- •Have never played organized sports
- •Have never been diagnosed with a concussion
排除标准
- •For both Soccer and Non-Athletic Control cohorts
- •any head, neck, or face injury in the 1 year prior to the study (e.g., concussion, eye injury);
- •history of vestibular, ocular, or vision dysfunction (e.g., macular degeneration)
- •currently taking any medications affecting balance (e.g., antibiotics)
- •any neurological disorders (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 minutes, CNS neoplasm, spinal cord injury/surgery, history of stroke)
- •hypertension, cardiac arrhythmia, or pulmonary disease
- •lower extremity injury that would prohibit normal walking
- •metal implants in the head
- •implantation of cochlear device, cardiac pacemaker, medical fusion device, intracardiac lines, or neurostimulator (e.g., DBS, epidural/subdural VNS)
- •history of severe injury to the bones, joints, or muscles in either arm
- •Session-specific exclusion criteria will include:
- •slept less than 4 hours before the 1st and 2nd test day (verified by the TMS screening questionnaire)
- •drank more than 3 alcoholic drinks or used recreational drugs 24 hours before the 1st and 2nd test day
- •drank more than 3 cups of coffee in an hour before test sessions
- •glasses are prohibited (contact lens are okay) for safety purpose for the heading intervention
研究组 & 干预措施
Soccer Heading
干预措施: Soccer Heading (Device)
Kicking-Control
干预措施: Soccer Heading (Device)
结局指标
主要结局
Changes in Brain-Derived Blood Biomarker Over Time in Relation to the Baseline
时间窗: Measured at four time points (pre-intervention, immediately post-intervention, 2 hours post, and 24 post)
Outcome measure will be the slope of increased (worsened) levels of blood biomarkers compared to the baseline and control group
Changes in Ocular-Motor Function Over Time in Relation to the Baseline
时间窗: Measured at four time points (pre-intervention, immediately post-intervention, 2 hours post, and 24 post)
Outcome measure will be the slope of increased (worsened) levels of ocular-motor performance compared to the baseline and control group
次要结局
未报告次要终点
研究者
Keisuke Kawata
Assistant Professor of Kinesiology
Indiana University