Epidural Stimulation After Neurologic Damage: Long-Term Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Volitional electromyography (EMG) power
研究概览
简要总结
This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.
详细描述
Participants will be enrolled in this study for the duration of 10 years. They will need to come to Minneapolis twice a year for the Brain Motor Control Assessment and will be given different settings within their Spinal Cord Stimulator (SCS) programing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •22 years of age or older
- •Able to undergo the informed consent process
- •Stable spinal cord injury
- •International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5
- •No ventilator dependency within the last year
- •American Spinal Injury Association (AISA) imparement scale"A" or "B" in the absence of spinal cord stimulation
- •Medically stable in the judgment of the Principal investigator
- •Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation and 2 months from spinal cord stimulator surgery
- •Has an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentation
- •Spinal imaging of the stimulator system
排除标准
- •Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator
- •Use of botulinum toxin (Botox) injections in the previous six months
- •Clinically significant mental illness in the judgment of the principal investigator
- •Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator
- •Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI
- •Current Pregnancy
- •Current pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.
研究组 & 干预措施
Volitional EMG power
Assessing the change in volitional EMG power during the Brain Motor Control Assement (BMCA) between nonstimulation baseline and stimulation.
干预措施: Epidural Spinal Cord Stimulation (Device)
结局指标
主要结局
Change in Volitional electromyography (EMG) power
时间窗: 10 years
The measurement of volitional change using EMG during the Brain Motor Control assessment between nonstimulation baseline and stimulation
次要结局
- Prediction of power preferences(10 years)