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Stability of Motor Output in Aging Adults

2015年3月5日 更新者:US Department of Veterans Affairs

Corticobulbar Motor Output in Aging Adults

The goal of this project is to examine the area of the brain that controls muscle movement for a group of muscles important for swallowing, and to see how that area changes over 2 weeks of time.

研究概览

地位

完全的

条件

详细说明

A large number of our nation's veterans develop dysphagia due to the myriad of potential etiological sources of swallowing disorders, including stroke and head and neck cancer. The Veteran's Health Administration has recently identified dysphagia as a major clinical focus for the VA system (Sullivan & Dennis, 2006). In order to accurately assess adaptations in motor cortex, it is first necessary to have a reliable tool for measuring organizational representation in the motor cortex. Transcranial magnetic stimulation (TMS) is a desirable choice for such measurement because of the ability to identify causative relationships between an area of motor cortex stimulated and muscle response. Therefore, the specific research objectives of this proposal are:

  1. To demonstrate the reproducibility of TMS mapping of the submental muscle group in healthy older adults between 60 and 80 years of age
  2. To determine the neural representation of submental musculature in the motor cortex of healthy older adults between 60 and 80 years of age.

Twenty healthy adults, 10 men and 10 women, between the ages of 60 and 80 years will serve as research participants. TMS will be used to establish motor maps of the submental muscles. Subjects will undergo two testing sessions, on day 1 and day 14. The results from each session will be compared to assess excitability and representation within the motor cortex, and to assess stability and reliability of measurement.

研究类型

观察性的

注册 (实际的)

20

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

    • Florida
      • Gainesville、Florida、美国、32608
        • North Florida/South Georgia Veterans Health System

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

60年 至 80年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Healthy adults between 60 and 80 years of age

描述

Inclusion Criteria:

  • Between 60 and 80 years of age

Exclusion Criteria:

  • History of dysphagia
  • History of neurologic disease
  • History of head or neck cancer
  • History of stroke
  • Untreated hypertension
  • History of a heart condition or heart disease
  • Currently pregnant
  • Contraindication to TMS including:

    • Metallic hardware on the scalp in the area where TMS will be applied
    • Cardiac pacemaker
    • Implanted medication pumps or an intracardiac line
    • Prior diagnosis of seizure or epilepsy in the subject (childhood history of benign febrile seizure will not be a contraindication)
    • Poorly controlled migraine headaches
    • Previous brain neurosurgery
    • Medications that can lower seizure threshold (Appendix B)
    • Unstable medical conditions
    • Lowest motor thresholds above 80% on TMS

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

队列和干预

团体/队列
1
20 healthy participants between 60 and 80 years of age. Ten men and 10 women.

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
Mean Motor Evoked Potential Amplitude for Submental Cortical Representation
大体时间:2 weeks
Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation. The mean sEMG amplitudes of the submental muscles for each of these sites is then calculated for the mean MEP measure.
2 weeks

次要结果测量

结果测量
措施说明
大体时间
Motor Map Center of Gravity
大体时间:2 weeks
Position on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles).
2 weeks
Area of Submental Representation
大体时间:2 weeks
Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation.
2 weeks

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。

调查人员

  • 首席研究员:Karen Hegland, PhD、North Florida/South Georgia Veterans Health System

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

2009年11月1日

初级完成 (实际的)

2011年10月1日

研究完成 (实际的)

2011年10月1日

研究注册日期

首次提交

2009年9月1日

首先提交符合 QC 标准的

2009年9月1日

首次发布 (估计)

2009年9月2日

研究记录更新

最后更新发布 (估计)

2015年4月8日

上次提交的符合 QC 标准的更新

2015年3月5日

最后验证

2014年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • C6697-M

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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