跳至主要内容
临床试验/NCT03305289
NCT03305289Unknown不适用

Brain Activity Assessment by Functional MRI Before, After Radiofrequency of Gasserian Ganglia in Patient With Trigeminal Neuralgia

Assiut University0 个研究点目标入组 20 人开始时间: 2020年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
主要终点
pain alleviation

研究概览

简要总结

To investigate the brain activations related to TN, using fMRI, and to evaluate changes in these activations following the application of pulsed and thermal Radiofrequency lesioning to the gasserien ganglion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 20 - 65 years
  • •Primary trigeminal neuralgia
  • •Maxillary and/or mandibular affection only
  • •Failure of medical treatment

排除标准

  • •2ry trigeminal neuralgia
  • •Recurrent trigeminal neuralgia
  • •Ophthalmic branch affection
  • •Contraindication for intervention (sepsis, coagulopathy, infection at entery point, local anesthetic allergy,...)
  • •Pregnancy

研究组 & 干预措施

pulsed radiofrequency

Active Comparator

sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then pulsed radiofrequency will be applied for 10 patients for 10 mins

干预措施: pulsed Radiofrequency (Procedure)

thermal Radiofrequency

Active Comparator

sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then Thermal lesion will be applied for 10 patients for 2 cycles of 90 seconds

干预措施: thermal Radiofrequency (Procedure)

结局指标

主要结局

pain alleviation

时间窗: 1 month

pain assessment by functional MRI

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

mohamed elsayed

assisstant lecture

Assiut University

相似试验