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临床试验/NCT05677243
NCT05677243招募中不适用

Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery

Centre Hospitalier Princesse Grace1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Pain relief

研究概览

简要总结

This study aims to evaluate the outcome of patient treated by radiosurgery on LINAC with high dose rate for classical trigeminal neuralgia

详细描述

This retrospective and prospective case-series hospital-based study will be conducted in all patients with trigeminal neuralgia treated by radiosurgery on LINAC at the Centre Hospitalier Princesse Grace from april 2018 to january 2028. Patients will be treated with frameless technic and receive 90 Gy delivered with high dose rate on the intra cisternal portion of the trigeminal nerve.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Classical trigeminal neuralgia according the International Classification of Headache Disorders
  • Trigeminal neuralgia resistant to the maximum tolerated medical therapy, with pain intensity according to the Barrow Neurological Institute (BNI) score IV or V.
  • Patients aged > 18

排除标准

  • Patients suffering from secondary Trigeminal neuralgia (tumour in the cerebellopontine angle, arteriovenous malformation or multiple sclerosis)
  • Previous history of radiosurgery procedure

结局指标

主要结局

Pain relief

时间窗: 24 months

Barrow Neurological Institute pain intensity scale - score I to V - V is the worst Barrow Neurological Institute (BNI) pain intensity scale Barrow Neurological Institute (BNI) pain intensity scale

次要结局

  • Toxicity of radiosurgery(1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years)
  • Variation of quality of life(1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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