Restoring Arm and Hand Function With Non-invasive Spinal Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Improvement in sensorimotor function in arms and hands
研究概览
简要总结
This study is to determine if non-invasive electrical stimulation of the spinal cord can help improve hand and arm function in people with paralysis who suffered a cervical spinal cord injury.
详细描述
This study is to determine if non-invasive electrical stimulation of the spinal cord can help improve hand and arm function in people with paralysis who suffered a cervical spinal cord injury. The investigators hypothesize that this stimulation can revive spared function in the spinal cord of individuals who are clinically paralyzed, but who have some remaining connections between the brain and spinal cord. Our research has demonstrated that modifying the activation state of the spinal cord 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 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
- 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
- •Spinal cord injury 1 or more years prior
- •Non progressive SCI at C7 or higher
- •Half of key muscles below neurological level having a motor score of less than 2/5
- •Ability to commit to home exercises and 12 week participation
- •Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in upper 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 upper 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 12 week study period
- •No current anti-spasticity regimen
- •Must not have received botox injections in the prior six months
- •Be unable to use upper extremity for functional tasks
排除标准
- •Pregnancy
- •No functional segmental reflexes below the lesion
结局指标
主要结局
Improvement in sensorimotor function in arms and hands
时间窗: 12 weeks
Subjects will be tested by several measures of sensory and motor function, as well as self-assessments regarding quality of life and independence, at the beginning of the study and at each testing session. These tests include: American Spinal Injury Association (ASIA) scoring system. Box and block CUE (Capabilities of Upper Extremity) GRASSP (Graded Redefined Assessment of Strength, Sensibility and Prehension) SCIM (Spinal Cord Independence Measure) Ashworth Spasticity scale: Penn Spasm Frequency VAS (Visual Analog Scale) for Spasticity)
次要结局
未报告次要终点