CURE-SCI. Clinical Utilization of CNS Growth Factor Release in Response to Electrical Stimulation Following Spinal Cord Injury.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- CSF Brain Derived Neurotrophic Factor (BDNF) Level
研究概览
简要总结
This research is being done to study the effect of Functional Electrical Stimulation (FES) cycling on factors in blood and spinal cord in people with spinal cord injury (SCI).
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. Although this device has been cleared by the Food and Drug Administration (FDA) for use by individuals with spinal cord injury, we are trying to find out the best way to use it in order to obtain the greatest benefits in an attempt to improve functional recovery.
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
- •History of traumatic spinal cord injury sustained at least 6 months prior
- •Complete spinal cord injury at any level American Spinal Injury Association (ASIA) impairment scale A
- •No use of functional electrical stimulation within 3 months
- •Medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
- •Legally able to make own health care decisions
排除标准
- •Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke, history of arrhythmia with hemodynamic instability
- •Uncontrolled hypertension (resting systolic blood pressure (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 (2) 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
研究组 & 干预措施
Group A
For 3 weeks, you will need to come to the ICSCI one (1) time per week during which you will perform FES cycling for 1 hour each.
干预措施: FES Cycling (Device)
Group A
For 3 weeks, you will need to come to the ICSCI one (1) time per week during which you will perform FES cycling for 1 hour each.
干预措施: Lumbar puncture (Procedure)
Group A
For 3 weeks, you will need to come to the ICSCI one (1) time per week during which you will perform FES cycling for 1 hour each.
干预措施: Mood assessment (Behavioral)
Group B
For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each.
干预措施: FES Cycling (Device)
Group B
For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each.
干预措施: Lumbar puncture (Procedure)
Group B
For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each.
干预措施: Mood assessment (Behavioral)
Group C
For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each.
干预措施: FES Cycling (Device)
Group C
For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each.
干预措施: Lumbar puncture (Procedure)
Group C
For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each.
干预措施: Mood assessment (Behavioral)
Group D
For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform cycling without FES for 1 hour each.
干预措施: Cycling without FES (Device)
Group D
For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform cycling without FES for 1 hour each.
干预措施: Lumbar puncture (Procedure)
Group D
For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform cycling without FES for 1 hour each.
干预措施: Mood assessment (Behavioral)
结局指标
主要结局
CSF Brain Derived Neurotrophic Factor (BDNF) Level
时间窗: At 3 weeks
We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.
CSF Brain Derived Neurotrophic Factor (BDNF) Level
时间窗: Baseline
We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.
次要结局
- Serum Brain Derived Neurotrophic Factor (BDNF) Level(At 3 weeks)
- Mood Assessment(3 weeks)
- CSF Growth Factor Quantification(At 3 weeks)
- Spasticity Testing Using the Modified Ashworth Scale (MAS)(At 3 weeks)
- Spasticity Testing Using the Modified Ashworth Scale (MAS)(Baseline)
- CSF Growth Factor Quantification(Baseline)
- Serum Brain Derived Neurotrophic Factor (BDNF) Level(Baseline)