Trigeminal Evoked Responses to Improve Rhizotomy
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
Trigeminal neuralgia (TGN) is a debilitating pain syndrome where electrical, shock- like jolts of pain affect the face. Trigeminal somatosensory evoked potentials (TSEPs) provide a promising modality for measuring the trigeminal sensory and nociceptive pathway by using peripheral stimulation of the trigeminal nerve (on the skin) and measuring low latency evoked potentials on the scalp (contralateral sensory cortex). While TSEPs have been measured in the past, it is not clear if implementing TSEPs into a routine neurosurgical rhizotomy procedure will be feasible. This is a prospective cohort study examining the feasibility of routinely performing TSEPs during rhizotomies for TGN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Adults of 18 years or older
- •Scheduled to undergo percutaneous rhizotomy for facial pain
排除标准
- •For TGN: Facial pain of unclear origin (i.e. not clearly TGN pain) or Rhizotomy procedure canceled
- •For Healthy control: Diagnosis or history of facial pain such as TMD or TGN, History of migraine, History of any functional pain disorder: fibromyalgia, IBS, CRPS or Recent chronic pain (within last month)
结局指标
主要结局
Feasibility
时间窗: 3 years
total study procedure completion rate
次要结局
- TSEPS latency between control and TGN patients(1 day)
- TSEPS peak to peak amplitude within TGN(1 day)
- TSEPS latency within TGN(1 day)
- TSEPS peak to peak amplitude between control and TGN patients(1 day)
