Evaluate Tactile Sensation and Proprioception in Lower Limb Amputees Using Neuromodulation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in stimulation as reported by patients
研究概览
简要总结
The purpose of this study is to investigate how leg amputee patients can feel sensations with neuromodulation while they are using a prosthetic leg. "Neuromodulation" is the process by which the nervous system can be regulated by targeted delivery of a stimulus, such as electrical stimulation or chemical agents, to specific neurological sites in the body. In this study, the investigators plan to use either electrical stimulation of the spinal cord (Spinal Cord Stimulation) or electrical stimulation of the dorsal root ganglion (DRG stimulation) as methods for neuromodulation.
Participation in this study will involve visiting the K-Lab (Human Performance Laboratory) at Duke's Sports Medicine Institute once prior to trial implant surgery, if feasible, and four times during the two weeks following the implantation of trial stimulation leads to evaluate sensations related to touch and position of the prosthetic leg as they are generated by neuromodulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Subject is at least 18 years of age
- •Subject is able and willing to comply with the schedule and protocol
- •Subject is a lower limb amputee who uses a prosthetic leg
- •Subject is a good candidate for implantation of a stimulator for their amputation related pain
- •Subject has stable neurological/cognitive function in the past 30 days
- •Subject is able to provide informed consent
排除标准
- •Subject is currently participating in a clinical investigation that includes an active treatment arm
- •Subject currently has an active implantable device including an Implantable Cardioverter Defibrillator (ICD), pacemaker, spinal cord stimulator, or intrathecal drug pump
- •Subject is a prisoner
- •Female subject whom are pregnant
结局指标
主要结局
Change in stimulation as reported by patients
时间窗: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in stimulation parameters as measured by frequency
时间窗: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in stimulation parameters as measured by pulse width
时间窗: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in stimulation parameters as measured by amplitude
时间窗: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in pain score as measured by McGill Pain Questionnaire
时间窗: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
次要结局
- Change in gait parameters as measured by step frequency(Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours))
- Change in passive movement detection as measured by external sensors(Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours))
- Change in cortical reorganization measured by Electroencephalogram (EEG)(Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours))