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The Effect of Cryotherapy on Cerebral Hemodynamics Within Healthy Subjects

2018年8月1日 更新者:Jacob Resch、University of Virginia
Upon suffering a concussion, a neurometabolic cascade including an increase in glucose and oxygen demand occurs for up to 48 hours post-insult.5 This period of increased glucose and oxygen demand is coupled with a period of hyperperfusion and decreased cerebral blood flow. 6-9 Cryotherapy in the musculoskeletal system has been shown to decrease tissue temperature, blood flow, oxygen and metabolic demands.10-17 Cryotherapy following moderate or severe traumatic brain injury has been demonstrated to decrease intracranial metabolic processes and oxygenation consumption.18-23 Although the benefits of cryotherapy have been established in moderate-severe TBI, the effects of superficial cranial cooling in individuals with and without concussion are unknown. The purpose of this randomized control trial is to evaluate the effects of superficial cryotherapy on cerebral blood flow and cognitive function in healthy, recreationally active young adults.

研究概览

地位

完全的

干预/治疗

详细说明

The prevalence of concussion has been estimated to be between 4,380 and 10,403 concussions per day in the United States annually with over an estimated 3 million visits to emergency departments each year.1 Symptoms following a concussion last up to 10 days for 90% of cases2; however, the reduction of symptoms in this time frame does not indicate full neurometabolic recovery.

Following concussion, a neurometabolic cascade of events immediately occurs following initial impact with return to normative values around 30 days post-injury. In an attempt to maintain homeostasis in the brain following impact, glucose and oxygen demand increases temporarily and are coupled with periods of increased hyperperfusion and decreased cerebral blood flow (CBF). Although the neurometabolic timeline immediately following impact is only generally understood, there is consensus upon acute increases in CBF and metabolic activity followed by decreased CBF until return to normative values.

Cryotherapy has been studied extensively for its' effects throughout the musculoskeletal system. Cryotherapy in the musculoskeletal system has been shown to decrease tissue temperature and blood flow, as well as decrease oxygen and energy demands.12-19 Cryotherapy has also been applied in cases of moderate or severe traumatic brain injury and has demonstrated to decrease intracranial metabolic processes and oxygenation consumption. Although the potential benefits of cryotherapy have been established in cases of moderate to severe traumatic brain injury (TBI), there is no current research examining cryotherapy in the treatment of concussion.

A convenience sample of 34 healthy, recreationally active individuals between the ages of 18-25 years will be recruited for participation in this study. The independent variable in this study will be group (cryotherapy, control). The primary outcome measures of interest are cognitive functioning measured using the Stroop Test and cerebral blood hemodynamics and hemoglobin saturation measured using near infrared spectroscopy. The pain visual analog scale (VAS) will be used to quantify tolerance to the intervention.

The following study will address the following objectives and related hypotheses:

Objective 1: To determine if the application of cryotherapy influences intracranial hemodynamics within healthy recreationally active young adults.

Hypothesis 1: Cryotherapy will cause a decrease in intracranial hemodynamics; specifically, the CO2 saturation and deoxygenated hemoglobin causing a decrease in intracranial metabolic activity.

Objective 2: To determine if the application of cryotherapy decreases cerebral blood flow within healthy recreationally active individuals.

Hypothesis 2: The application of cryotherapy will not cause a change in cerebral blood flow due to the highly regulated central nervous system.

研究类型

介入性

注册 (实际的)

34

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Virginia
      • Charlottesville、Virginia、美国、22904
        • University of Virginia Memorial Gymnasium

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 25年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Between 18 and 25 years of age
  • Recreationally active (exercise at least 30 minutes, 3 times weekly)

Exclusion Criteria:

  • Contraindications for cryotherapy (eg. Raynaud's phenomenon, cold urticaria)
  • Any documented learning difficulty or disability
  • Any known neurological or psychiatric disorder
  • History of migraines
  • History of a concussion or traumatic brain injury in past 6 months
  • Currently taking psychotropic medications
  • Any known metabolism diseases
  • Any known hematological diseases
  • Any recreational drug use in past month
  • Any known cardiopulmonary impairments or pathologies

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Cryotherapy
Participants received superficial cryotherapy using the Cryohelmet(TM)
Cryotherapy was administered using the Catalyst CryoHelmet™ (All-Star Sporting Goods®, Shirley, Massachusetts, USA). The CyroHelmet is a flexible helmet equipped with gel ice packs meant to cool the head and neck.
无干预:Control
Participants sat quietly for 20 minutes

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Oxygenated blood
大体时间:Oxygenated blood was collected throughout the data collection period (45 minutes)
Oxygenated blood based on functional near-infrared spectroscopy (fNIRS) data output
Oxygenated blood was collected throughout the data collection period (45 minutes)
Deoxygenated blood
大体时间:Dexoygenated blood was collected throughout the data collection period (45 minutes)
Deoxygenated blood based on functional near-infrared spectroscopy (fNIRS)
Dexoygenated blood was collected throughout the data collection period (45 minutes)
Stroop Task reaction time
大体时间:Stroop Task reaction time was collected prior to and following the intervention. Each test took approximately 5 minutes to complete.
Reaction time measured in milliseconds while completing the Stroop Task
Stroop Task reaction time was collected prior to and following the intervention. Each test took approximately 5 minutes to complete.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年3月22日

初级完成 (实际的)

2017年5月1日

研究完成 (实际的)

2018年3月13日

研究注册日期

首次提交

2017年6月9日

首先提交符合 QC 标准的

2017年6月9日

首次发布 (实际的)

2017年6月14日

研究记录更新

最后更新发布 (实际的)

2018年8月2日

上次提交的符合 QC 标准的更新

2018年8月1日

最后验证

2018年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 19706

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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