CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- CSF BDNF Levels in Subjects With Inflammatory Myelopathy
研究概览
简要总结
This research is being done to see how different amounts of Functional Electrical Stimulation (FES) affect cycling on factors in blood and spinal cord in people with spinal cord inflammation.
详细描述
FES cycling is a method of applying low level electrical currents to the leg and buttock muscles to cause the weakened or paralyzed muscles to contract and produce a cycling motion of the legs. The FES cycling in this study will be done through a device called the RT300-SL Cycle Ergometer (RT300).
Although this device has been cleared by the Food and Drug Administration (FDA) for use by individuals with neurological disorders, we are trying to find out the best way to use it in order to obtain the greatest results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Male, Female, age 18-65, all ethnic groups
- •History of inflammatory myelopathy with onset at least 3 months prior
- •No FES ergometer (i.e. RT300 or equivalent) use within 1 month
- •Subject is medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
- •Subject is legally able to make own health care decisions
- •Access to telephone with texting capabilities
- •English language proficiency
排除标准
- •Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke New York Heart Association (NYHA) Class III or IV, history of arrhythmia with hemodynamic instability.
- •Uncontrolled hypertension (resting systolic BP>160mmHg or diastolic BP >100mmHg consistently)
- •Concurrent lower motor neuron disease such as peripheral neuropathy that would exclude lower extremity electrical excitability
- •Unstable long bone fractures of the lower extremities
- •Subjects who are unwilling to agree to two cerebrospinal fluid (CSF) examinations (lumbar punctures)
- •Presence of cardiac pacemaker and/or defibrillator
- •Presence of cancer
- •History of epileptic seizures
- •Subjects having a Stage 2 or greater sacral decubitus ulcer
- •Women who are pregnant
- •Active drug or alcohol use or dependence
结局指标
主要结局
CSF BDNF Levels in Subjects With Inflammatory Myelopathy
时间窗: Baseline
We will measure cerebrospinal fluid (CSF) concentrations of BDNF in response to FES ergometry. We will investigate whether there is a correlation between plasma and CSF BDNF concentrations.
次要结局
- Mood Assessment(3 weeks)
- Spasticity Testing Using the Modified Ashworth Scale (MAS)(3 weeks)
- CSF Growth Factor Quantification(3 weeks)
- Serum Brain Derived Neurotrophic Factor (BDNF) Level(3 weeks)