Intraoperative Peripheral Nerve Stimulation
2026年6月17日 更新者：Wake Forest University Health Sciences
Intraoperative Electrical Stimulation to Accelerate Functional Recovery of Peripheral Nerves After Decompressive Surgery
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.
研究概览
地位
撤销
条件
详细说明
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.
研究类型
介入性
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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North Carolina
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Winston-Salem、North Carolina、美国、27157
- Atrium Health Wake Forest Baptist
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Nerve Root Stimulation Arm
patients undergoing spine surgery for decompression of the nerve root
|
in addition to standard of care surgical decompression will receive 10 minutes of electrical stimulation at an amplitude of 2 mA with the Checkpoint nerve stimulator to the nerve root at the time of decompressive surgery
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实验性的：Peripheral Nerve Stimulation Arm
patients undergoing peripheral nerve decompression in an upper extremity
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in addition to standard of care surgical decompression will receive 10 minutes of electrical stimulation at an amplitude of 2 mA with the Checkpoint nerve stimulator to the peripheral nerve at the time of decompressive surgery
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有源比较器：Nerve Root Control Arm
patients undergoing spine surgery for decompression of the nerve root
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standard surgical treatment when undergoing spine surgery for decompression of the nerve root
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有源比较器：Peripheral Nerve Control Arm
patients undergoing peripheral nerve decompression in an upper extremity
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standard surgical treatment when undergoing peripheral nerve decompression in an upper extremity
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Medical Research Council Scale for Muscle Strength Score
大体时间：Baseline
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The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.
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Baseline
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Medical Research Council Scale for Muscle Strength Score
大体时间：Month 1
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The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.
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Month 1
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Medical Research Council Scale for Muscle Strength Score
大体时间：Month 3
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The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.
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Month 3
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Medical Research Council Scale for Muscle Strength Score
大体时间：Year 1
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The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.
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Year 1
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Oswestry Disability Index Score
大体时间：Baseline, Month 1, Month 3, Year 1
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Participants in the nerve root stimulation arm will be given the The Oswestry Disability Index which is a self-administered questionnaire used to measure permanent functional disability caused by low back pain.
It consists of 10 items covering pain and physical activities, with scores ranging from 0 (no disability) to 100 (maximum disability).
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Baseline, Month 1, Month 3, Year 1
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Patient Reported Outcomes Measurement Information System (PROMIS) Score
大体时间：Baseline, Month 1, Month 3, Year 1
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Score range from 20-80 with high scores indicating better function while lower scores indicate poorer function.
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Baseline, Month 1, Month 3, Year 1
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Disabilities of the Arm Shoulder and Hand Score
大体时间：Baseline, Month 1, Month 3, Year 1
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Participants in the peripheral nerve stimulation arm will be given the Disabilities of the Arm Shoulder and Hand questionnaire which is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales.
Scores range from 0 (no disability) to 100 (most severe disability).
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Baseline, Month 1, Month 3, Year 1
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Short Form Health Survey Score
大体时间：Baseline, Month 1, Month 3, Year 1
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Participants in the peripheral nerve stimulation arm will be given the SF-36.
There are 36 items with score range from 0-100 with a higher score indicating a better functional state with few limitations/disabilities while a low score indicates a poorer functional state with more disability and limitations.
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Baseline, Month 1, Month 3, Year 1
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Christopher Dibble, MD、Atrium Health Wake Forest Baptist
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2029年6月1日
研究完成 (估计的)
2029年6月1日
研究注册日期
首次提交
2026年5月11日
首先提交符合 QC 标准的
2026年5月11日
首次发布 (实际的)
2026年5月18日
研究记录更新
最后更新发布 (实际的)
2026年6月22日
上次提交的符合 QC 标准的更新
2026年6月17日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.