Evaluation of the Percutaneous Spinal Cord Stimulation Trial Using the Dermatomal Somatosensory Evoked Potentials (DSSEP) Collision Testing
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of Participants With Positive Collision
研究概览
简要总结
This study is to objectively evaluate the success of a spinal cord stimulator (SCS) trial using testing (DSSEP) to determine if the paresthesia (tingling sensation) or pain reduction achieved correlates with the degree of stimulation.
详细描述
The SCS trial leads will be placed as per standard of care, using fluoroscopic guidance and leads will be checked for proper positioning. Leads will be tested for appropriate paresthesia coverage of the patient's painful area(s), using multiple electrode configurations and lead positions (dependent on the location of the pain). After the leads are secured, the patient will be sent to the recovery room where the DSSEP test will be performed. A technologist will glue/tape recording electrodes to the patient's head, neck, back or legs. One or two stimulating electrodes are also placed on the patient's leg. Each electrode is checked with a meter to ensure proper functioning. Pulsing stimulus will start in one of the stimulating electrodes. Each time a different area is tested, the pulsing will be started again. Each area tested will take 10-15 minutes. The painful dermatomal distribution area, specific to each patient will be used for dermatomal SSEP stimulation. Placement will be correlated with nerve roots involved with the corresponding dermatomes. Measurements will be obtained to determine collision criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 subject will be eligible for inclusion in this study only if all the following criteria apply:
- •A. Subject understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities.
- •B. Subjects are male or female greater than 18 years old at the time of screening visit.
- •C. Pain in one or both lower extremities. D. Pain is not responding to conservative treatment such as physical therapy or medications.
- •E. Average pain rating of at least 4 on a scale 0 to 10, on average, prior to enrollment in the study.
- •F. Patient is mentally competent to make decisions.
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •A. Female subject with childbearing potential (a premenopausal female, who is not surgically sterile).
- •B. Subjects who poorly cooperate or have any cognitive impairment. C. Patient with severe concomitant depression. D. Inability to communicate adequately with physician and /or study coordinator.
- •E. Patient is diagnosed with a psychiatric condition that will likely interfere with diagnostic accuracy of the workup protocol or with recovery following the anticipated procedure
研究组 & 干预措施
DSSEP
DSSEP testing after SCS trial lead placement
干预措施: DSSEP (Device)
结局指标
主要结局
Number of Participants With Positive Collision
时间窗: Day 1
Positive collision: 75% or greater decrease in amplitude from the baseline waveform. Centroparietal (CPz)-Popliteal Fossa (Fpz) cortical montage (images) will be used as primary montage to evaluate collision results.
次要结局
未报告次要终点