Monitoring the Effect of Epidural Stimulation on Sensorimotor and Autonomic Functions in Chronic Patients With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Brain functional connectivity
研究概览
简要总结
Investigators propose to demonstrate that epidural stimulation (ES) can be used to recover significant levels of autonomic control of cardiovascular, urinary and sexual 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. In addition investigators suggest to prove on functional magnetic resonance imaging if there are some significant changes before and after the stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-progressive SCI with complete motor paralysis below T1; American Spinal Injury Association Impairment Scale (AIS) A or B
- •18 - 60 years of age;
- •longer than 2 years post injury;
- •stable medical condition
- •unable to voluntarily move all single joints of the legs;
- •spinal cort lesion between C7 and Th10
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 hypovolemia; and HIV or AIDS related illness.
结局指标
主要结局
Brain functional connectivity
时间窗: 1 year after implantation
Researchers want to describe if there are some changes on functional MRI of the spinal cord and brain before and after stimulation. With functional MRI in rest and task condition, the functional connectivity (FC) is examined.
Change from baseline of lower extremity independence time during after 1 year of stimulation
时间窗: 1 year after stimulation (360 training sessions)
Researchers will measure the amount of time individuals are able to stand without manual assistance (independently).
次要结局
- Change in sense of wellbeing as measured by the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire(3 month, 6 month, 9 month, 12 month)
- Change in trunk stability restoration(6 month and 1 year after implantation)
- Neurogenic bowel symptoms will be measured using the Neurogenic Bowel Dysfunction (NBD) score.(3 month, 6 month, 9 month, 12 month)
- Reduction of neuropathic pain(3 month, 6 month, 9 month, 12 month)
- Sexual function as measured by the Sexual Function Questionnaire(3 month, 6 month, 9 month, 12 month)
- Neurogenic bladder symptoms will be measured using the Neurogenic Bladder Symptom Score (NBSS).(3 month, 6 month, 9 month, 12 month)
- Symptoms of spasticity will be measured by Modified Ashworth spasticity test(3 month, 6 month, 9 month, 12 month)
- Change in BP during the head up tilt test (HUTT)(6 month -1 year)
研究者
Vojtech Rybka, MD
Principal Investigator
University Hospital, Motol