Effects of Transvertebral Direct Current Stimulation in Humans
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in corticospinal excitability
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Decubitus ulcers which interfere with harness support or walking
- •Severe orthostatic hypotension
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.
次要结局
未报告次要终点
研究者
Lumy Sawaki
Associate Professor
University of Kentucky