Treatment of Chronic Refractory Pain by Combined Deep Brain Stimulation of the Anterior Cingulum and Sensory Thalamus: a Feasibility and Safety Study
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Chronic Refractory Neuropathic Pain
- 发起方
- Centre Hospitalier Universitaire de Nice
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Feasibility of ACC-DBS: success the process of surgical intervention
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
Deep brain stimulation (DBS) of the sensory thalamus has been proposed for 40 years to treat medically refractory neuropathic pain, but its efficacy remains partial and unpredictable. Recently, bilateral DBS of the dorsal anterior cingulate cortex (ACC), a brain region involved in the integration of the affective and cognitive aspects of pain, has been successively proposed to treat few patients suffering from refractory chronic pain, by decreasing the emotional impact of their chronic pain. ACC-DBS could be an alternative or complementary approach to thalamic DBS in these patients, but the consequences of chronic dACC-DBS on cognition and affects have not been studied specifically.
The primary objective is to evaluate the feasibility and safety of bilateral ACC-DBS combined with unilateral thalamic DBS in patients suffering from chronic unilateral pain, refractory to medical treatment. Secondary objective will evaluate the efficacy of this combined DBS compared to thalamic DBS only.
详细描述
Chronic pain represents a major personal and societal burden, especially for medically resistant patients. Deep brain stimulation (DBS) of the sensory thalamus has been proposed for 40 years to treat medically refractory neuropathic pain, but its efficacy remains partial and unpredictable. Recently, bilateral DBS of the dorsal anterior cingulate cortex (ACC), a brain region involved in the integration of the affective, emotional and cognitive aspects of pain, has been successively proposed to treat few patients suffering from refractory chronic pain. In a pilot study, 16 patients treated by ACC-DBS experienced a significant improvement of their quality of life despite a slight decrease of their pain intensity, by improving the affective and emotional impacts of their chronic pain. ACC-DBS could be an alternative or complementary approach to thalamic DBS in these patients. However the consequences of chronic dACC-DBS on cognition and affects have not been studied specifically. The primary objective of this study is to evaluate the feasibility and safety of bilateral ACC-DBS combined with unilateral thalamic DBS in patients suffering from chronic unilateral pain, refractory to medical treatment. Secondary objective will evaluate the efficacy of this combined DBS compared to thalamic DBS only
研究者
入排标准
入选标准
- •adult patients (age 18-70 years old) suffering from chronic (duration \>1 year) unilateral neuropathic pain
- •severe (VAS score \>6/10)
- •with high emotional impact (HAD subscores \> 10) considered as resistant to medication specific to neuropathic pain at sufficient doses and durations (including at least antiepileptics and antidepressants) and not sufficiently improved by rTMS and relevant surgical solutions.
- •Non inclusion criteria:
- •previous history of stroke,
- •cognitive impairment (MMSE score \<24),
- •DSMIV axis I psychiatric disorder,
- •contra-indication to surgery, anesthesia or MRI;
- •patient responder to rTMS,
排除标准
- 未提供
结局指标
主要结局
Feasibility of ACC-DBS: success the process of surgical intervention
时间窗: Day 0
Feasibility of ACC-DBS will be evaluated by the proportion of patients undergoing with success the process of surgical intervention Safety will be evaluated by neurological examination
Occurence of serious adverse events.
时间窗: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
description of serious adverse events
Feasibility of ACC-DBS : neurological success of the process of chronic stimulation
时间窗: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
neurological success of the process of chronic stimulation will be evaluated by the neurological examination
Feasibility of ACC-DBS : psychiatric success of the process of chronic stimulation
时间窗: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
psychiatric success of the process of chronic stimulation will be evaluated by the psychiatric assessment
Feasibility of ACC-DBS : cognitive success of the process of chronic stimulation
时间窗: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
cognitive success of the process of chronic stimulation will be evaluated by the cognitive assessment
次要结局
- Efficacy of ACC-DBS : change of quality of life by EQ-5D(Day 0, Month 1, Month 4, Month 7, Month 10, Month 22)
- Efficacy of ACC-DBS : change of quality of life by SF-36(Day 0, Month 1, Month 4, Month 7, Month 10, Month 22)
- Efficacy of ACC-DBS : change of pain intensity(Day 0, Month 1, Month 4, Month 7, Month 10, Month 22)