The Combined Effects of Hypoxia and Subconcussive Head Impacts on Neurocognitive Function: a Pilot Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Acute change in brain-derived blood biomarkers from pre-heading at 0 hour post-heading
研究概览
简要总结
The purpose of this study is to examine the combined effects of hypoxia and a short bout of subconcussive head impacts on neurocognitive and ocular-motor function and plasma expression of brain-derived blood biomarkers.
详细描述
The purpose of the pilot study is to observe preliminary trends in neural response to subconcussive head impacts in hypoxic condition. This work will provide a critical un-tested knowledge regarding the combined effects of subconcussion and hypoxic condition (mimicking high altitude), which will be used in our upcoming grant proposal to the Department of Defense (DoD). Military personnel, particularly those who are deployed to Afghanistan, are constantly subjected to hypoxic condition, given that the majority of military land operations in Afghanistan occur at 2000-3000 meters (6500-10,000 feet). This level of altitude does not elicit major side effects, yet neural functions may experience some degree of perturbation (i.e., slowed reaction time, altered night vision). Concurrently, these military personnel, who operate at high altitudes, often incur subconcussive forces to the head. These subconcussive head impacts can be induced by exposure to, for example, flash-bang grenades, artillery fire, recoilless rifle, improvised explosive devices (IEDs), and head collision. The combined effects of these two stressors have the potential to attenuate one's readiness, operational efficiency, and overall brain function, but the combined effects have never been studied to date. As a result, one of four study topics that the Defense Centers of Excellence deems urgent is: Document the effects of altitude exposure on mild traumatic brain injury (mTBI) and blast-induced neurotrauma (BINT). To answer the question, we hypothesized that there will be an exponential worsening in neurocognitive function and in ocular-motor system functioning, and increased plasma expression of brain-derived biomarkers, after subconcussive head impacts under hypoxic conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Between 18 and 26 years old
- •Current or former soccer player (i.e., collegiate, intramural, club, professional)
- •At least 3 years of soccer heading experience
- •Participants can read and speak English
- •Participants have cell phone or computer with internet access to schedule for follow-up visits via email or text message
- •Participant is willing to refrain from participating in any sport activity that purposefully uses one's head to maneuver (American football, ice-hockey, rugby, wrestling, and soccer heading) during study participation
排除标准
- •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 that trigger drowsiness
- •Pregnancy
- •Any history of 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)
- •Lower extremity injury that would prohibit normal walking
- •Metal implants in the head
- •Conditional Exclusion Criteria
- •Based on participants' self report: those who meet any of the following criteria, he/she will be either excluded or rescheduled (if they still wish to participate in the study):
- •Slept less than 4 hours during the night prior to the testing day
- •Consumed more than 3 alcoholic drinks within 24h prior to testing
- •Used recreational drugs 24h prior to the testing day
- •Consumed more than 300 mg of caffeine (the equivalent of about 3 cups of coffee) within 1h before testing sessions
结局指标
主要结局
Acute change in brain-derived blood biomarkers from pre-heading at 0 hour post-heading
时间窗: Blood samples will be collected at pre- and 0 hour post-heading
Blood samples will be collected and centrifuged at 1500 x g for ten minutes at 4 degree celsius. Plasma will be aliquoted and stored at -80 degree celsius until analysis. Plasma samples will be assayed for neurofilament-light (NfL), glial fibrillary acidic protein (GFAP), and tau.
Acute change in convergence function from pre-heading at 0 hour post-heading
时间窗: Conversion function will be assessed at pre- and 0 hour post-heading
Participants will undergo near-point of convergence (in centimeter) to evaluate how closely one can visualize a moving target without double vision occurs.
Acute change in neurocognitive function from pre-heading at 0 hour post-heading
时间窗: Neurocognitive function will be assessed at pre- and 0 hour post-heading
Participants will complete a computerized neurocognitive assessment (Immediate Post-Concussion Assessment and Cognitive Testing).
次要结局
- Acute change in saccadic eye movement function from pre-heading at 0 and 24 hour post-heading(Saccadic eye movement function will be assessed at pre- , 0, and 24 hour post-heading)
- Change in ocular-motor function at 24 hours post-heading follow-up(Ocular-motor function will also assessed at 24 hours post-heading)
- Change in neurocognitive function at 24 hours post-heading follow-up(Neurocognitive function will also assessed at 24 hours post-heading)
- Change in brain-derived blood biomarkers at 24 hours post-heading follow-up(A third blood sample will be collected at 24 hours post-heading)
- Acute change in smooth eye pursuit function from pre-heading at 0 and 24 hour post-heading(Smooth eye pursuit function will be assessed at pre- , 0, and 24 hour post-heading)
研究者
Keisuke Kawata
Assistant Professor Kinesiology
Indiana University