跳至主要内容
临床试验/NCT04586777
NCT04586777
终止
不适用

Effects of Transvertebral Direct Current Stimulation in Humans

University of Kentucky1 个研究点 分布在 1 个国家目标入组 27 人2014年1月15日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Spinal Cord Injuries
发起方
University of Kentucky
入组人数
27
试验地点
1
主要终点
Change in corticospinal excitability
状态
终止
最后更新
5年前

概览

简要总结

This study will evaluate the effects of non-invasive stimulation of the spinal cord in people with spinal cord injury.

详细描述

This study will use a non-invasive form of spinal stimulation, called transvertebral direct current stimulation, or tvDCS. It currently is not clear what effects this type of stimulation has on the excitability of the brain and spinal cord in people with spinal cord injury. In this study, subjects will participate in 3 sessions, with at least 1 week in between sessions, during which they will get a different condition of tvDCS. We will test the excitability of the brain and spinal cord before and after tvDCS in each session.

注册库
clinicaltrials.gov
开始日期
2014年1月15日
结束日期
2021年1月8日
最后更新
5年前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Principal Investigator
主要研究者

Lumy Sawaki

Associate Professor

University of Kentucky

入排标准

入选标准

  • 18 to 65 years of age
  • Motor incomplete spinal cord injury classified as B, C, or D by the American Spinal Injury Association Impairment Scale (AIS)
  • More than 12 months post-injury
  • Lesion at of above thoracic level T8
  • Body mass index \<30 (in order to facilitate reliable location of body landmarks guiding stimulation)
  • Severe gait deficit

排除标准

  • Unstable cardiopulmonary conditions
  • History of seizure, head injury with loss of consciousness, severe alcohol or drug abuse, and/or psychiatric illness
  • Cognitive deficits severe enough to preclude informed consent
  • Positive pregnancy test of being of childbearing age and not using appropriate contraception
  • Ferromagnetic material in the brain or in the spine (except for titanium for segmental fixation of the spine)
  • Cardiac or neural pacemakers
  • Fixed contractures in the lower extremities
  • Uncontrolled diabetes
  • Severe osteoporosis
  • Severe spasticity

结局指标

主要结局

Change in corticospinal excitability

时间窗: Immediately before tvDCS, Immediately after tvDCS

This will be measured using transcranial magnetic stimulation to evoke responses in muscles of the lower leg.

Change in spinal cord excitability

时间窗: Immediately before tvDCS, Immediately after tvDCS

Hoffmann's reflex will be used to assess spinal cord excitability. For this text, pulses of electrical stimulation will be applied to the back of the knee and the response will be measured from the calf muscle.

研究点 (1)

Loading locations...

相似试验