Neuromodulation Training for Upper Extremity Recovery for Chronic Cervical Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Neuro Recovery Scale ( NRS).
研究概览
简要总结
This study is to understand how the combination of activity-based recovery training and targeted spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hand, arms, and core.
详细描述
This study is to understand how the combination of activity-based recovery training and targeted spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hand, arms, and core. Activity-based recovery training aims to advance independence without the use of assistive devices. Spinal cord transcutaneous stimulation is an electrical stimulation that is provided on top of the skin over specific areas of the spinal cord to activate the circuitry for the activity that is being trained and reconnect with pathways between the brain and spinal cord.
i) Physical evaluation by the clinician or physician including the Classification of Spinal Cord Injury (ISNCSCI exam. ii) A series of tests to evaluate the trunk, arm function with and without using tests to evaluate muscle activation. iii) A series of questionnaires to evaluate function and quality of life iv) Two separate Magnetic Resonance Imaging (MRI) of spinal column (head to hip).
Randomized to one of three groups:
Group 1: will be upper extremity training with transcutaneous spinal stimulation of the spine combined with upper extremity and trunk rehabilitation. The group will complete 60 training sessions transcutaneous spinal stimulation.
Group 2: will be upper extremity training with transcutaneous spinal stimulation of the spine combined with upper extremity and trunk rehabilitation. The group will complete 40 training sessions of transcutaneous spinal stimulation. The group will then complete 20 sessions of rehabilitation therapy of the upper extremities and trunk (no stimulation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age.
- •spinal cord injury for greater than or equal to 6 months.
- •spinal cord injury at a cervical neurologic level of injury.
排除标准
- •ventilator dependent.
- •history of fractures.
- •pressure sore or skin issues.
- •history of illicit drug abuse.
- •history of cardiac, respiratory, bladder, renal or other medical disorder unrelated to spinal cord injury.
- •bladder Botox injections less than 12 months prior.
- •muscle Botox injections less than 12 months prior.
- •colostomy bag or urostomy.
- •implanted pump (i.e., baclofen pump, pain pump, etc).
- •If I am female: I am pregnant at the time of enrollment or planning to become pregnant during the course of the study.
- •unable to wean from anti-spasticity medication.
- •contraindications to MRI imaging (pacemaker, metallic foreign body, aneurysm clip, etc.)
结局指标
主要结局
Neuro Recovery Scale ( NRS).
时间窗: 6 months
Measure of the degree a person who has sustained a spinal cord injury (SCI) has recovered the ability to perform functional tasks relative to how the individual performed these tasks prior to injury. The NRS consists of a numeric version of the visual analog scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. This type of scale can be administered verbally.
次要结局
未报告次要终点
研究者
Gail Forrest
Director, Center for Spinal Stimulation
Kessler Foundation