A Theranostic Tool to Assess and Enable Spared Spinal Motor Function After SCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Improvement in sensorimotor function in the lower extremities
研究概览
简要总结
This study is to determine if non-invasive electrical stimulation of the spinal cord can be used to: 1) assess spared function following a spinal cord injury; and 2) be use for rehabilitation.
详细描述
This study is to determine if non-invasive electrical stimulation of the spinal cord can be used to: 1) assess spared function following a spinal cord injury; and 2) be use for rehabilitation.
The investigators hypothesize that this type of stimulation can be used to locate and determine if any spinal (nerve) pathways or connections were spared following a spinal cord injury. We also hypothesize the same stimulation can help revive or recover function to muscles connected to these spared spinal (nerve) pathways in individuals who are clinically paralyzed. Our research has demonstrated that modifying the activation state of the spinal cord after an injury, or awakening the spinal cord, can benefit people with paralysis years after a spinal cord injury. This method and device have not yet been approved by the FDA for the treatment of paralysis and are under investigation. This study if successful will help provide further evidence that could be use to one day to gain FDA approval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, 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
- •SCI ASIA A, B, C
- •Spinal cord injury 1 or more years prior
- •Non progressive cervical or thoracic SCI
- •Half of key muscles below neurological level having a motor score of less than 2/5
- •Ability to commit to home exercises and 16 week participation
- •Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in lower extremity rehabilitation or testing activities
- •Not dependent on ventilation support
- •No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or urinary tract infection that might interfere with lower extremity rehabilitation or testing activities
- •No clinically significant depression or ongoing drug abuse
- •Adequate social support network to be able to participate in weekly training and assessment sessions for the duration of the 16 week study period
- •No current anti-spasticity regimen
- •Must not have received botox injections in the prior six months
- •Be unable to use lower extremity for functional tasks
排除标准
- •Pregnancy
- •No functional segmental reflexes below the lesion
研究组 & 干预措施
Grp#1: sham stimulation
Group #1: Baseline clinical assessment; followed by two weeks training with no stimulation; then four weeks training + sham Transcutaneous Electrical Spinal Cord Stimulation; followed by repeat clinical assessment; then four weeks training + effective non-sham Transcutaneous Spinal Cord Stimulation; repeat clinical assessment.
Secondary outcome measurements: assess ability to stand with and without stimulation using a stance frame support; assess trunk function (core stability) with and without stimulation
干预措施: Transcutaneous Electrical Spinal Cord Stimulation (Device)
Grp#2: Control
Group #2: Baseline clinical assessment; followed by two weeks training with no Transcutaneous Electrical Spinal Cord Stimulation; then four weeks training + effective Transcutaneous Electrical Spinal Cord Stimulation; followed by repeat clinical assessment.
Secondary outcome measurements: assess ability to stand with and without stimulation using a stance frame support; assess trunk function (core stability) with and without stimulation
干预措施: Transcutaneous Electrical Spinal Cord Stimulation (Device)
结局指标
主要结局
Improvement in sensorimotor function in the lower extremities
时间窗: 10-12 weeks
Subjects will be tested by several measures of sensory and motor function, as well as self assessments of spasticity, quality of life, and independence. These tests include: American Spinal Injury Association (ASIA) scoring system, Spinal Cord Independence Measure (SCIM), Ashworth Spasticity Scale, Penn Spasm Frequency, Visual Analog Scale (VAS) for Spasticity, Electromyographic (EMG) recordings, Joint angle (goniometer) measures, kinematic analysis.
次要结局
- Ability to stand independently(2-4 weeks)