Monitoring & Mitigation of Neurologic Injuries to Optimize Resilience After Repetitive Head Impacts
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 350
- 试验地点
- 6
- 主要终点
- Optical Coherence Tomography (OCT) of Cerebrospinal Fluid Thickness in the Macula (Part of the Retina)
研究概览
简要总结
The purpose of this Phase 2, double-arm study is to identify repetitive, non-concussive head impacts that impair neurologic functioning, and to test treatments that can mitigate these effects and return functioning to normal as quickly as possible.
详细描述
Up to 350 total collegiate athletes and athlete-cadets will be enrolled. Approximately 290 participants participating in varsity contact sports (e.g. soccer, football, etc.) at colleges/universities or military colleges, and up to 60 non-contact athletes/cadets participating in non-contact varsity sports (e.g. swimming, tennis, etc.) will be recruited as controls for the Observational arm; approximately half the participants will be female.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age ≥ 18 years
- •Collegiate athlete or athlete-cadet anticipated to be an active member of a varsity sport team.
排除标准
- •Any head, neck, or face injury in the 3 months prior to enrollment that precludes participation in contact sports or wearing a mouth guard sensor
- •History of neurological or psychiatric disorders or neurological disorders that impact electrical activity in the brain (such as seizure disorders), or diagnosed learning disability, that in the opinion of the investigator, would interfere with participation in the study.
- •Participants currently undergoing active treatment for migraine, depression and/or anxiety or ADHD will not be excluded as these are high prevalence conditions in the adolescent and collegiate population (8-30%). However, exploratory stratified analyses will be conducted where possible.
- •Participants with eye conditions or diseases that could impact the blood vessels in the eye.
- •Determination that the participant is unsuitable for study entry or potentially unable to complete all aspects of the study based on the judgement of the Site Investigator or Study PI.
研究组 & 干预措施
Observational (Ad-Lib Exercise) Arm
All participants will undergo neurologic outcome testing with optical coherence tomography/angiography (OCT/A) at pre- and post-season and 2 weeks after the end of the season. For two weeks at the end of the sport season, participants will be instructed to refrain from sports involving head contact but to otherwise exercise ad-lib.
Intervention (Exercise or Stretching) Arm
Athletes and athlete cadets will be administered OCT/A and a novel neurologic test battery at pre- and post-season, and 2 weeks after the end of the season. After the end-of-season assessments, participants will be randomized to 2 weeks of either 30 minutes of daily aerobic exercise or to 30-minutes of prescribed stretching.
干预措施: Aerobic exercise (Other)
结局指标
主要结局
Optical Coherence Tomography (OCT) of Cerebrospinal Fluid Thickness in the Macula (Part of the Retina)
时间窗: Pre-season and post-season, 2 weeks
A primary OCT variables examined will be macula cerebrospinal fluid (CSF) thickness (an indicator of the gain or loss of neurons or glia in the inner nuclear, ganglion cell and nerve fiber layer).
Change in Blood Serum Concentrations of Glial Fibrillary Acidic Protein (GFAP)
时间窗: Baseline 4 to 7 months
Glial Fibrillary Acidic Protein (GFAP) concentration will determine if there is a 11.9 pg/mL or greater change in GFAP in each participant over the course of the study.
Change in Blood Serum Concentration of Neurofilament light chain (NfL) in a blood sample
时间窗: Baseline 4 to 7 months
The neurologic test battery consists of blood draws for serum brain proteins: Neurofilament light chain (NfL) concentrations will be observed for changes over the course of the study.
Change in p-231Tau serum concentration in a blood sample
时间窗: Baseline 4 to 7 months
The neurologic test battery consists of blood draws for serum brain proteins: p231Tau will be observed for changes over the course of the study.
Change in Concussion Index as measured with Quantitative Electroencephalogram (qEEG)
时间窗: Baseline 4 to 7 months
The Quantitative Electroencephalogram (qEEG) Concussion Index (CI) includes measures of power (absolute and relative), mean frequency, connectivity (asymmetry, coherence, phase lag, phase synchrony), complexity (fractal dimension and scale-free activity), and information theory (entropy), across and within frequency bands.
Change in near-point convergence (NPC)
时间窗: Baseline 4 to 7 months
Near point of convergence (NPC) is a measurement of how close an object can be brought to the eyes while the eyes are focused on it.
Change in Choice reaction time (CRT)
时间窗: Baseline 4 to 7 months
Choice reaction time (CRT) refers to the time it takes for a person to react to a stimulus by selecting a specific response from multiple options.
Change in blink reflex test
时间窗: Baseline 4 to 7 months
A blink reflex test, also known as a corneal reflex test, is a non-invasive procedure that measures the electrical activity of the facial nerves when stimulated.
Optical Coherence Tomography (OCT) to detect signs of neurodegenertaion in the Retina
时间窗: Pre-season and post-season, 2 weeks
OCT will be used to measure the cup-to-disc ratio of the optic disc, and indicator of neurodegeneration.
Optical Coherence Tomography/Angiography (OCT/A) to assess the vascular structure in the retina
时间窗: Pre-season and post-season, 2 weeks
Retinal vascular structure will be acquired using the OCT angiography (OCT/A). The primary OCT/A variable examined will be foveal avascular zone (FAZ) area reflecting the size of the central portion of the macula which contains no blood vessels, and which increases in size with loss of capillaries in the surrounding region).
次要结局
未报告次要终点
研究者
Jeffrey Bazarian
Professor
University of Rochester