Abstract：
BACKGROUND: 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. Recent pilot studies of DBS targeting the ACC, a brain region involved in the integration of the affective, emotional, and cognitive aspects of pain, may improve patients suffering from refractory chronic pain. ACC-DBS could be complementary to thalamic DBS to treat both the sensory-discriminative and the affective components of chronic pain, but the safety of combined DBS, especially on cognition and affects, has not been studied.
METHODS: We propose a prospective, randomized, double-blind, and bicentric study to evaluate the feasibility and safety of bilateral ACC-DBS combined with unilateral thalamic DBS in adult patients suffering from chronic unilateral neuropathic pain, refractory to medical treatment. After a study period of six months, there is a cross-over randomized phase to compare the efficacy (evaluated by pain intensity and quality of life) and safety (evaluated by repeated neurological examination, psychiatric assessment, cognitive assessment, and assessment of affective functions) of combined ACC-thalamic DBS and thalamic DBS only, respectively.
CONCLUSIONS: The EMOPAIN study will show if ACC-DBS is a safe and effective therapy for patients suffering from chronic unilateral neuropathic pain, refractory to medical treatment. The design of the study will, for the first time, assess the efficacy of ACC-DBS combined with thalamic DBS in a blinded way.
METHODS: We propose a prospective, randomized, double-blind, and bicentric study to evaluate the feasibility and safety of bilateral ACC-DBS combined with unilateral thalamic DBS in adult patients suffering from chronic unilateral neuropathic pain, refractory to medical treatment. After a study period of six months, there is a cross-over randomized phase to compare the efficacy (evaluated by pain intensity and quality of life) and safety (evaluated by repeated neurological examination, psychiatric assessment, cognitive assessment, and assessment of affective functions) of combined ACC-thalamic DBS and thalamic DBS only, respectively.
CONCLUSIONS: The EMOPAIN study will show if ACC-DBS is a safe and effective therapy for patients suffering from chronic unilateral neuropathic pain, refractory to medical treatment. The design of the study will, for the first time, assess the efficacy of ACC-DBS combined with thalamic DBS in a blinded way.
摘要：
背景：感觉丘脑的深部脑刺激（DBS）已经提出了40年，用于治疗医学上难治性神经性疼痛，但它的疗效仍然是部分的和不可预测的。最近针对ACC的DBS的试点研究，参与情感整合的大脑区域，情感,和疼痛的认知方面，可以改善患有难治性慢性疼痛的患者。ACC-DBS可以补充丘脑DBS，以治疗慢性疼痛的感觉辨别和情感成分，但是联合DBS的安全性，特别是在认知和影响方面，没有被研究过。
方法：我们提出了一种前瞻性的，随机化，双盲,双中心研究评估双侧ACC-DBS联合单侧丘脑DBS治疗成人慢性单侧神经性疼痛的可行性和安全性，难以治疗。经过六个月的研究，有一个交叉的随机阶段，以比较疗效（通过疼痛强度和生活质量评估）和安全性（通过重复的神经系统检查评估，精神病学评估,认知评估，和情感功能的评估）仅合并ACC-丘脑DBS和丘脑DBS，分别。
结论：EMOPAIN研究将显示ACC-DBS对于患有慢性单侧神经性疼痛的患者是否是安全有效的治疗方法，难以治疗。研究的设计将，第一次,以盲法评估ACC-DBS联合丘脑DBS的疗效。
方法：我们提出了一种前瞻性的，随机化，双盲,双中心研究评估双侧ACC-DBS联合单侧丘脑DBS治疗成人慢性单侧神经性疼痛的可行性和安全性，难以治疗。经过六个月的研究，有一个交叉的随机阶段，以比较疗效（通过疼痛强度和生活质量评估）和安全性（通过重复的神经系统检查评估，精神病学评估,认知评估，和情感功能的评估）仅合并ACC-丘脑DBS和丘脑DBS，分别。
结论：EMOPAIN研究将显示ACC-DBS对于患有慢性单侧神经性疼痛的患者是否是安全有效的治疗方法，难以治疗。研究的设计将，第一次,以盲法评估ACC-DBS联合丘脑DBS的疗效。
