The Effect of Chronic Cannabis Use on Neural Response to Acute Subconcussive Head Impacts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Acute change in brain-derived blood and saliva biomarkers from pre to 2 hour post-heading
研究概览
简要总结
The purpose of this pilot study is to better understand the effects of chronic cannabis (THC) use on the neural responses to subconcussive head impacts, as a form of repetitive soccer headings. The study is designed to identify the physiological changes of cannabis using cohort (THC) and compare it to a nonusing cohort in order to see if the responses to 20 controlled bouts of soccer headings are exacerbated by the chronic cannabis use, diminished to less of a response, or unchanged, through an array of neurologic measures, including cognitive function, ocolar-motor function, autonomic function, and blood biomarkers. The hypothesis is that repetitive subconcussive head impacts will impair cognitive function in worse memory, attention span, and visual and verbal problem solving; this impairment will be greater in the chronic cannabis use groups than non-using group. The blood and salivary biomarkers neurofilament light (NFL) and glial fibrillary acidic protein (GFAP) will be measured in plasma, with the hypothesis that repetitive subconcussive head impacts will significantly increase plasma NFL and GFAP level at 24 hours-post heading and decrease by 72 hours-post heading, while remaining undetectable at 2 hours-post heading; the chronic cannabis use groups will see more severe effects on ocular-motor function than the non-using group. The study aims to determine the differences in acute effects of subconcussive head impacts on eye movement, attention, and language function between chronic cannabis use subjects and non-using subjects by evaluating ocular-motor function with near point of convergence and King-Devick tests. The hypothesis is that repetitive subconcussive head impacts will significantly increase impairments of eye movements, attention, and language function, as well as near point of convergence; the chronic cannabis use groups will see more severe effects on hampered ocular-motor function than the non-using group. Lastly, there is a cold pressor test to assess autonomic nerve function, with the hypothesis that repetitive subconcussive head impacts will decrease autonomic nerve function in chronic cannabis use patients to a greater degree than non-using subjects.
详细描述
NUMBER OF PEOPLE TAKING PART IN THE STUDY
We plan to recruit 45 THC using subjects and 45 non-using subjects.
PROCEDURES FOR THE STUDY
Participants will be assigned to the THC cannabis user group or the nonuser group based on participants' report of past cannabis use. These groups will then be verified using saliva and urine tests for cannabis use history.
The study consists of 4 test sessions during a 4-day period. The 1st day will take approximately 4 hours. The 2nd and 4th day will each take approximately 1 hour. Participants will not need to do anything on the 3rd day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Dr. Kawata (PI) will only know subjects' group assignment and ensure blinded experiment and data processing. They will assign participants into two groups, chronic cannabis users and non-users. Group assignment will be based on self-reported cannabis use history and confirmed on 1st day of the study, with a saliva test ensuring no recent (24h-prior) use and a urine test to confirm history of chronic cannabis use or no use. Under the strict supervision of Dr. Kawata, experienced research assistants will perform soccer heading protocol, blood draws, neurocognitive and ocular-motor testing. Statistician will be blinded from group assignment. These processes will ensure single blind method
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 Chronic THC User Group
- •being between 18 to 26 years of age
- •self-reported chronic THC use (average use once per week but not dependent)3) at least 3 years of soccer heading experience.
- •For Non-User Cohort
- •being between 18 to 26 years of age
- •self-reported non cannabis use in the past 6 months
- •at least 3 years of soccer heading experience
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 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 performing soccer headings
- •metal implants in the head
- •Session-specific exclusion criteria will include:
- •used cannabis within the last 72 hours (verified by saliva cannabis test before intervention)
- •slept less than 4 hours before the 1st and 2nd test day (verified by screening questionnaire)
- •drank any alcoholic drinks or used recreational drugs 72 hours before the 1st test day and during the study period.
- •drank more than 3 cups of coffee before any test sessions
- •glasses are prohibited (contact lenses are okay) for safety purpose for the heading intervention
结局指标
主要结局
Acute change in brain-derived blood and saliva biomarkers from pre to 2 hour post-heading
时间窗: Blood and saliva samples will be collected at pre- and 2 hour post-heading
Blood samples will be collected and centrifuged at 1500 x g for ten minutes at 4 degree celsius. Serum and saliva samples will be aliquoted and stored at -80 degree celsius until analysis. Serum and saliva samples will be assayed for S100B, neurofilament-light (NfL), glial fibrillary acidic protein (GFAP), and tau, and UCH-L1. All expression levels in pg/mL.
Acute change in brain-derived blood and saliva biomarkers from pre to 24 hour post-heading
时间窗: Blood samples will be collected at pre- and 24 hour post-heading
Blood samples will be collected and centrifuged at 1500 x g for ten minutes at 4 degree celsius. Serum and saliva samples will be aliquoted and stored at -80 degree celsius until analysis. Serum and saliva samples will be assayed for S100B, neurofilament-light (NfL), glial fibrillary acidic protein (GFAP), and tau, and UCH-L1. All expression levels in pg/mL.
Acute change in neurocognitive function from pre to 2 hour post-heading
时间窗: Neurocognitive function will be assessed at pre- and 2 hour post-heading
Participants will complete a computerized neurocognitive assessment (Immediate Post-Concussion Assessment and Cognitive Testing).
Acute change in ocular-motor function from pre to 24 hour post-heading
时间窗: Ocular-motor function will be assessed at pre- and 24 hour post-heading
Participants will undergo 2 ocular-motor assessments: 1) near-point of convergence and 2) King-Devick Test--a brief assessment of saccadic eye movements, attention, and visual and language processing.
Acute change in neurocognitive function from pre to 24 hour post-heading
时间窗: Neurocognitive function will be assessed at pre- and 24 hour post-heading
Participants will complete a computerized neurocognitive assessment (Immediate Post-Concussion Assessment and Cognitive Testing).
Acute change in ocular-motor function from pre to 2 hour post-heading
时间窗: Ocular-motor function will be assessed at pre- and 2 hour post-heading
Participants will undergo 2 ocular-motor assessments: 1) near-point of convergence and 2) King-Devick Test--a brief assessment of saccadic eye movements, attention, and visual and language processing.
次要结局
- Acute change in ocular-motor function from pre to 72 hour post-heading(Ocular-motor function will be assessed at pre- and 72 hour post-heading)
- Acute change in autonomic nerve function from pre to 24 hour post-heading(Autonomic response will be assessed at pre- and 24 hour post-heading)
- Acute change in brain-derived blood and saliva biomarkers from pre to 72 hour post-heading(Blood and saliva samples will be collected at pre- and 72 hour post-heading)
- Acute change in neurocognitive function from pre to 72 hour post-heading(Neurocognitive function will be assessed at pre- and 72 hour post-heading)
- Acute change in autonomic nerve function from pre to 2 hour post-heading(Autonomic response will be assessed at pre- and 2 hour post-heading)
- Acute change in autonomic nerve function from pre to 72 hour post-heading(Autonomic response will be assessed at pre- and 72 hour post-heading)
研究者
Keisuke Kawata
Assistant Professor
Indiana University