Pulse-width Modulation During Pedicle Screw Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- CMAP response under three different pulse-width settings
研究概览
简要总结
The overarching aim of this project is to modulate the pulse-width during stimulation of pedicle screws and record the response thresholds associated with each PWM setting. During this initial phase of the investigation, no further data will be collected.
详细描述
In vivo electrical stimulation of pedicle screws is a well-documented modality for evaluating potential breach of the pedicle wall. However, previous research has focused primarily on the stimulation threshold intensity required to elicit a neurophysiological response. Other stimulation parameters, such as pulse-width, remain uninvestigated. The goal is to obtain data on the pulse-width vs. CMAP relationship.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •A patient will be eligible for study participation once they have been booked for a surgery involving pedicle screw placement and intraoperative neuromonitoring.
排除标准
- •The study excludes neonates, minors, pregnant women, prisoners and cognitively impaired patients.
研究组 & 干预措施
Pedicle Screw Stimulation Arm
干预措施: Pulse width modulation (Diagnostic Test)
结局指标
主要结局
CMAP response under three different pulse-width settings
时间窗: Within operating room upon completion of pedicle screw placement. 1 day
Upon completion of the pedicle screw placements, each screw will be stimulated utilizing three different pulse-width settings, 0.4 milliseconds, 0.2 milliseconds, and 0.05 milliseconds. The stimulation intensity required to elicit a compound muscle action potential (CMAP) will be recorded for each pulse-width parameter. This is measured in microvolts (uV).
次要结局
未报告次要终点
研究者
Linton T. Evans
Dr. Linton Evans
Dartmouth-Hitchcock Medical Center