Intraoperative Electrical Stimulation to Accelerate Functional Recovery of Peripheral Nerves After Decompressive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
The purpose of this research study is to find out if using direct electrical stimulation during surgery is safe and helpful for people with nerve problems caused by compressed nerves.
详细描述
The overall objective of this study is to establish the safety and utility of direct electrical stimulation as part of surgical intervention for compressive neuropathies of peripheral nerves and nerve roots. Stimulation will be provided with the Checkpoint Guardian which is a single-use, hand-held device cleared for the stimulation of exposed motor nerves or muscle tissue to locate and identify nerves. The central hypothesis is that electrical stimulation of the peripheral nerve or spinal nerve root at the time of decompressive surgery will improve motor strength and functional outcomes for patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
researcher measuring patient reported outcomes will be blinded to the treatment participants received
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
- •Nerve root stimulation arm: Clinical and radiographic findings of compressive neuropathy at the level of the nerve root, including myelopathy and/ or radiculopathy, who are planning for minimally invasive or open spine surgery to decompress the nerve.
- •Peripheral nerve stimulation arm: Compressive peripheral neuropathy, including cubital tunnel, carpal tunnel and peroneal nerve compression who are planning to undergo surgical decompression in the affected upper extremity.
排除标准
- •Patients that had previous nerve transfers for cervical spinal cord injury or tendon transfers, as they would not benefit from this procedure.
- •Any implanted electronic devices, including pacemakers
- •Pregnant or nursing
研究组 & 干预措施
Nerve Root Stimulation Arm
patients undergoing spine surgery for decompression of the nerve root
干预措施: Nerve Root Electrical Stimulation (Device)
Peripheral Nerve Stimulation Arm
patients undergoing peripheral nerve decompression in an upper extremity
干预措施: Peripheral Nerve Electrical Stimulation (Device)
Nerve Root Control Arm
patients undergoing spine surgery for decompression of the nerve root
干预措施: Standard Treatment - Nerve Root (Other)
Peripheral Nerve Control Arm
patients undergoing peripheral nerve decompression in an upper extremity
干预措施: Standard Treatment - Peripheral Nerve (Other)