Direct Stimulation Of Spinal Nerve Roots To Determine Sensory And Motor Innervation Patterns
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Lahey Clinic
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Build a database of spinal nerve root innervation utilizing direct nerve root stimulation
研究概览
简要总结
The purpose of this study is to collect data while monitoring muscles and nerves during spine surgery. The data being collected and analyzed will be used to learn more about how the body's nerves and muscles are distributed and develop a map of human muscle innervation patterns.
详细描述
In this large scale study it is proposed to examine root-to-muscle innervation directly, using the standard Intra-Operative Monitoring procedures during scheduled cervical and lumbar spinal surgeries. The study would directly map muscle and sensory distributions of nerve root innervations with no additional risk to patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing either cervical or lumbar cord procedures at Lahey Clinic and during which the surgeon has requested intra-operative neurophysiologic monitoring.
- •Surgery performed by a neurosurgeon
- •Participant must be ≥ 18 years of age or ≤ 85 years of age
- •Participant, or legally authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the Lahey Clinic IRB
排除标准
- •Past medical history significant for any of the following:
- •Peripheral Neuropathy
- •Patients with Diabetes Mellitus
- •Neuromuscular disease that would interfere with intra-operative recordings
- •The Investigator determines that the patient should not be included in the study for reason(s) not already specified
结局指标
主要结局
Build a database of spinal nerve root innervation utilizing direct nerve root stimulation
时间窗: Data collected during surgery and a 30 day post-op visit
次要结局
- Compare clinical symptoms of the patient to the direct muscle activation via spinal nerve root stimulation(Data collected during surgery and a 30 day post-op visit)