Studying Electromyographic Activity in Patients With Upper Limb Amputations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Number of separate sensory percepts evoked
研究概览
简要总结
The primary purpose of this study is to determine the extent to which the Regenerative Peripheral Nerve Interface ( i.e. reinnervation of partial muscle grafts by residual peripheral nerves) enables both the generation of high-performance motor control signals for prosthetic limbs, and the input of sensory percepts by electrical stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •For the prosthetic control graft arm:
- •Must have previously undergone upper limb amputation
- •Must be otherwise healthy (e.g. no severe pain syndromes or untreated mental health disorders)
- •Must be American Society of Anesthesiologists (ASA) Class I (low surgical risk)
- •Must have sufficient soft tissue quality to support performance of the operative procedures
- •Must have NOT previously received the partial muscle graft surgery
- •For the neuroma graft arm:
- •Must have previously undergone upper limb amputation
- •Must be otherwise healthy (e.g. no severe pain syndromes or untreated mental health disorders)
- •Must have previously received the partial muscle graft surgery
- •For the able-bodied arm:
- •Must have NOT undergone upper limb amputation
- •Must be in good health
排除标准
- •For the prosthetic control graft arm:
- •Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring, may not be appropriate candidates for inclusion in the study
- •For the able-bodied arm:
- •Participants with a history of nerve pain may not be appropriate candidates for inclusion in the study
研究组 & 干预措施
Neuroma Graft
In this arm, participants have already had partial muscle grafts placed on the amputated nerves to control neuroma growth. The investigators will place small electrodes percutaneously into the muscle grafts to record EMG signals and electrically stimulate the implanted nerves.
干预措施: Fine wire EMG electrodes (Other)
Prosthetic Control Graft
In this arm, participants will have an initial surgery to place partial muscle grafts on the amputated nerves. After a healing period, the investigators will place small electrodes percutaneously into the muscle grafts to record EMG signals and electrically stimulate the implanted nerves.
干预措施: Fine wire EMG electrodes (Other)
Able Bodied
The investigators will place small electrodes percutaneously into intact muscles in the arm to record EMG signals and electrically stimulate the intact nerves nearby.
干预措施: Fine wire EMG electrodes (Other)
结局指标
主要结局
Number of separate sensory percepts evoked
时间窗: <4 hours
Amplitude of EMG signal
时间窗: <4 hours
次要结局
未报告次要终点
研究者
Paul Cederna
Robert Oneal Professor and Chief of Plastic Surgery; Professor, Biomedical Engineering
University of Michigan