Spasticity and Functional Recovery in Humans With Acute to Subacute Spinal Cord Injury.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Modified Ashworth scale (MAS)
研究概览
简要总结
Spasticity is one of the most common symptoms manifested in humans with spinal cord injury (SCI). However, the neural mechanisms underlying the development of spasticity over time after an acute SCI are not yet understood. Using electrophysiological and imaging techniques along with traditional measurements of neurological recovery in the acute rehabilitation setting including physical exam and functional assessments; the investigators aim to examine the relationship between development of spasticity, residual descending motor pathways and functional and neurological recovery in humans with SCI from acute to subacute phase
详细描述
The purpose of this study is to measure changes to motor-evoked potentials (MEPs) and to evaluate if the development of spasticity is related to residual descending motor pathways and to a better neurological recovery and functional improvement in individuals with SCI from the acute to the subacute phase. The investigators will also test for the presence of biological markers in the blood that may correlate with levels of spasticity or neurological recovery and functional improvement, including the presence or absence of neuroplastic genetic polymorphisms (e.g. BDNF Val66Met polymorphism), as well as circulating levels of neuroplastic (e.g. BDNF) or inflammatory factors (e.g. interleukins, TNF) that may affect neuronal growth and functional restoration.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Modified Ashworth scale (MAS)
时间窗: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
This clinical scale will be used by measuring resistance encountered during manual passive muscle stretching using a six-point ordinal scale (0=no increase in tone, 1/+1=slight increase in tone with a catch and release or minimal resistance at the end or less than half of the range of movement, respectively, 2=more marked increased tone through most of the range of movement but affected parts easily moved, 3=considerable increase in tone and passive movement difficultly, and 4=affected parts rigid)
Motor evoked potential (MEP)
时间窗: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
Transcranial magnetic stimulation will be delivered and the coil will be positioned over the vertex and moved around this point to determine the optimal position for eliciting a motor evoked potentials (MEPs) in legs muscles.
First swing test (FST)
时间窗: From the time of admission to the hospital and enrolled in the study till the time of the discharge (up to 12 weeks)
We will use the pendulum test to measure muscle tone at the knee by using gravity to provoke muscle stretch reflexes during passive swinging of the lower limb.
次要结局
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)(From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks))
- Circulating biomarkers of inflammation and neuroplasticity(From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks))
研究者
Monica Perez
Principal Investigator
Shirley Ryan AbilityLab