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临床试验/NCT00970736
NCT00970736已完成不适用

Corticobulbar Motor Output in Aging Adults

US Department of Veterans Affairs1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Mean Motor Evoked Potential Amplitude for Submental Cortical Representation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between 60 and 80 years of age

排除标准

  • 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

结局指标

主要结局

Mean Motor Evoked Potential Amplitude for Submental Cortical Representation

时间窗: 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.

次要结局

  • Motor Map Center of Gravity(2 weeks)
  • Area of Submental Representation(2 weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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