Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion: a Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Demonstrating the feasibility of the intervention by assessing protocol completion without deviation
研究概览
简要总结
The aim of this study is to assess the feasibility of deep brain stimulation for refractory trigeminal neuralgia due to a pontine lesion, as is usually seen in the context of multiple sclerosis.
These patients usually have severe intractable facial pain and current medical and surgical options generally fail to achieve long lasting pain relief.
Hoping to improve pain control in this population, the investigators of this trial propose a novel technique consisting of implanting a deep brain stimulation lead within the pontine lesion to modulate the generation of pain signals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Adults of at least 18 years old
- •Refractory trigeminal neuralgia : failure of at least 3 drugs and at least two lesioning surgical interventions (radiosurgery, percutaneous rhizotomy, or open rhizotomy).
- •Pontine lesion proved by MRI in contact with trigeminal nerve tract
排除标准
- •Absolute contraindication to MRI
- •Medical contraindication to the procedure
研究组 & 干预措施
Deep brain stimulation
Implantation of deep brain stimulation lead within the pontine lesion
干预措施: Deep brain stimulation (Device)
结局指标
主要结局
Demonstrating the feasibility of the intervention by assessing protocol completion without deviation
时间窗: 24 months
Protocol completion defined by: * Lead implantation with success * Adjustment of stimulation parameters to minimize adverse effects * Minimal follow-up of 6 months after intervention
次要结局
- Lead implantation accuracy(24 months)
- Pain evolution(24 months)
- Facial numbness(24 months)
- Complications(24 months)
- Quality of life progression(24 months)
- Patient acceptability of the procedure(24 months)
- Patient global impression of change(24 months)