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临床试验/NCT05738096
NCT05738096招募中早期 1 期

Trigeminal Evoked Responses to Improve Rhizotomy

University of Minnesota2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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