Fontaine Denys, Leplus Aurélie, Donnet Anne, Darmon Nelly, Balossier Anne, Giordana Bruno, Simonet Benoit, Isan Petru, Regis Jean, Lanteri-Minet Michel
Department of Neurosurgery, Université Côte d'Azur, CHU de Nice, Nice, France.
Université Côte d'Azur, UR2CA, Nice, France.
J Headache Pain. 2025 Feb 17;26(1):35. doi: 10.1186/s10194-025-01967-8.
Deep Brain Stimulation (DBS) of the anterior cingulum has been recently proposed to treat refractory chronic pain but its safety and its efficacy have not been evaluated in controlled conditions. Our objective was to evaluate the respective feasibility and safety of sensory thalamus (Thal-DBS) combined with anterior cingulate (ACC-DBS) DBS in patients suffering from chronic neuropathic pain.
We conducted a bicentric study (clinicaltrials.gov NCT03399942) in patients suffering from medically-refractory chronic unilateral neuropathic pain surgically implanted with both unilateral Thal-DBS and bilateral ACC-DBS, to evaluate successively: Thal-DBS only; combined Thal-DBS and ACC-DBS; ACC-DBS "on" and "off" stimulation periods in randomized cross-over double-blinded conditions; and a 1-year open phase. Safety and efficacy were evaluated by repeated neurological examination, psychiatric assessment, comprehensive assessment of cognitive and affective functioning. Changes on pain intensity (Visual Analogic Scale) and quality of life (EQ-5D scale) were used to evaluate DBS efficacy.
All the patients (2 women, 6 men, mean age 52,1) completed the study. Adverse events were: epileptic seizure (2), transient motor or attention (2), persistent gait disturbances (1), sleep disturbances (1). No patient displayed significant cognitive or affective change. Compared to baseline, the quality of life (EQ-5D utility score) was significantly improved during the ACC-DBS "On" stimulation period (p = 0,039) and at the end of the study (p = 0,034).
This pilot study confirmed the safety of anterior cingulate DBS alone or in combination with thalamic stimulation and suggested that it might improve quality of life of patients with chronic refractory neuropathic pain.
The study has been registered on 20,180,117 (clinicaltrials.gov NCT03399942).
最近有人提出对前扣带回进行深部脑刺激（DBS）来治疗难治性慢性疼痛，但其安全性和有效性尚未在对照条件下得到评估。我们的目的是评估感觉丘脑（丘脑-DBS）联合前扣带回（ACC-DBS）DBS在慢性神经性疼痛患者中的各自可行性和安全性。
我们对患有药物难治性慢性单侧神经性疼痛且接受了单侧丘脑-DBS和双侧ACC-DBS手术植入的患者进行了一项双中心研究（clinicaltrials.gov NCT03399942），以依次评估：仅丘脑-DBS；联合丘脑-DBS和ACC-DBS；在随机交叉双盲条件下ACC-DBS的“开”和“关”刺激期；以及1年的开放期。通过重复的神经学检查、精神评估、认知和情感功能的综合评估来评估安全性和有效性。使用疼痛强度（视觉模拟量表）和生活质量（EQ-5D量表）的变化来评估DBS的疗效。
所有患者（2名女性，6名男性，平均年龄52.1岁）完成了研究。不良事件有：癫痫发作（2例）、短暂性运动或注意力问题（2例）、持续性步态障碍（1例）、睡眠障碍（1例）。没有患者出现明显的认知或情感变化。与基线相比，在ACC-DBS“开”刺激期（p = 0.039）和研究结束时（p = 0.034），生活质量（EQ-5D效用评分）显著改善。
这项初步研究证实了单独或联合丘脑刺激进行前扣带回DBS的安全性，并表明其可能改善慢性难治性神经性疼痛患者的生活质量。
该研究已在2018年1月17日注册（clinicaltrials.gov NCT03399942）。
