Recovery of Cardiovascular Function With Epidural Stimulation After Human Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Mean Arterial Blood Pressure in Response to Epidural Stimulation
研究概览
简要总结
We propose to demonstrate that epidural stimulation (ES) can be used to recover significant levels of autonomic control of cardiovascular and respiratory function as well as the ability to voluntarily control leg movements below the injury level. This intervention would provide an immediate therapeutic alternative to individuals who now have no recourse for treatment.
详细描述
We will enroll 4 research participants who have sustained a motor complete SCI to participate in the proposed experiments. Participants will be screened for eligibility, followed by 80 days of usual care, epidural implantation, 80 days of cardiovascular epidural stimulation training, 80 days of voluntary movement (VM) epidural stimulation training and finally 80 days of stand epidural stimulation training. These interventions are done in sequential order, however they are cumulative. In between each intervention, participants will undergo motor and cardiovascular experiments and assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-progressive SCI with complete motor paralysis above T1; American Spinal Injury Association Impairment Scale (AIS) A, B or C;
- •21 - 70 years of age;
- •greater than 2 years post injury;
- •stable medical condition;
- •unable to voluntarily move all single joints of the legs;
- •cardiovascular dysfunction including presence of persistent resting blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension; and
- •respiratory dysfunction including at least 15% deficit in predicted pulmonary function outcomes;
排除标准
- •ventilator dependent;
- •painful musculoskeletal dysfunction, unhealed fracture, contracture, or pressure sore that might interfere with training;
- •clinically significant depression or ongoing drug abuse;
- •cardiovascular, respiratory, bladder, or renal disease unrelated to SCI;
- •severe anemia (Hgb<8 g/dl) or hypovelemia; and
- •HIV or AIDS related illness.
研究组 & 干预措施
Epidural Stimulation
80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing.
干预措施: 5-6-5 Specify electrode (Device)
Epidural Stimulation
80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing.
干预措施: Restore Advance Pulse Generator (Device)
结局指标
主要结局
Mean Arterial Blood Pressure in Response to Epidural Stimulation
时间窗: 20 months
Noninvasive continuous blood pressure measured from a finger cuff by plethysmographic technique (Finometer Pro, FMS, Amsterdam, Netherlands) was calibrated to brachial blood pressure. Mean arterial pressure was calculated as one-third of systolic blood pressure plus two-third of diastolic blood pressure.
次要结局
未报告次要终点
研究者
Susan Harkema
Professor
University of Louisville