Pizzo Francesca, Carron Romain, Laguitton Virginie, Clement Audrey, Giusiano Bernard, Bartolomei Fabrice
Department of Epileptology and Cerebral Rhythmology, APHM, Timone Hospital, Marseille, France.
Aix Marseille Univ, INSERM, INS, Inst Neurosci Syst, Marseille, France.
Front Neurol. 2024 Dec 10;15:1480819. doi: 10.3389/fneur.2024.1480819. eCollection 2024.
This study aims to evaluate the efficacy and safety of deep brain stimulation (DBS) of the medial pulvinar nucleus (PuM) in reducing seizure frequency and addressing comorbidities in patients with drug and vagal nerve-resistant focal epilepsy.
This is an open-label prospective treatment trial with a planned enrollment of 12 patients suffering from medically refractory epilepsy (Clinical trial gov NCT04692701), for which the interim 12-month post-implantation results for the first 6 patients are being reported. Inclusion criteria were focal epilepsy not suitable for or after failed surgical intervention and previous failure of neurostimulation therapies (vagus nerve stimulation or anterior thalamic nucleus DBS). Evaluations included seizure diaries, neuropsychological assessments, and scales for depression, anxiety, quality of life, and seizure severity. PuM DBS was performed using ROSA robotic assistance, with follow-ups every 3 months for 1 year.
Out of six patients, five completed 1-year follow-up (one patient died prematurely). A non-significant trend toward seizure reduction was observed at 6 months, becoming more pronounced at 1 year (mean reduction: 45%; responders: 2/5). Seizure severity significantly improved ( = 0.02), with a reduction in the NHS3 scale scores. Quality of life improved significantly at 1 year ( = 0.03). Psychiatric assessments indicated a non-significant trend toward improvement in depression (mean improvement: 26%) and anxiety (mean improvement: 20%) scores. Neuropsychological testing showed stable or improved cognitive performance in three out of five patients. Adverse events included one case of cerebral hemorrhage, one infection leading to device removal, and one possible SUDEP.
Preliminary results suggest that PuM DBS may offer a promising therapeutic option for reducing seizure severity and improving quality of life and cognitive functions in patients with drug-resistant epilepsy. Despite the small sample size and the presence of serious adverse events, the findings warrant further investigation with larger cohorts to confirm these trends and optimize the treatment protocol.
本研究旨在评估内侧丘脑枕核（PuM）深部脑刺激（DBS）在降低药物难治性和迷走神经难治性局灶性癫痫患者癫痫发作频率及解决合并症方面的疗效和安全性。
这是一项开放标签的前瞻性治疗试验，计划招募12例药物难治性癫痫患者（临床试验注册号NCT04692701），本文报告了前6例患者植入后12个月的中期结果。纳入标准为不适合手术干预或手术干预失败以及先前神经刺激疗法（迷走神经刺激或丘脑前核DBS）失败的局灶性癫痫。评估包括癫痫发作日记、神经心理学评估以及抑郁、焦虑、生活质量和癫痫发作严重程度量表。采用ROSA机器人辅助进行PuM DBS，随访1年，每3个月一次。
6例患者中，5例完成了1年随访（1例患者过早死亡）。6个月时观察到癫痫发作减少的趋势不显著，1年时变得更加明显（平均减少：45%；反应者：2/5）。癫痫发作严重程度显著改善（P = 0.02），NHS3量表评分降低。1年时生活质量显著改善（P = 0.03）。精神科评估表明抑郁（平均改善：26%）和焦虑（平均改善：20%）评分有不显著的改善趋势。神经心理学测试显示5例患者中有3例认知表现稳定或改善。不良事件包括1例脑出血、1例因感染导致装置移除以及1例可能的不明原因癫痫性猝死。
初步结果表明，PuM DBS可能为降低药物难治性癫痫患者的癫痫发作严重程度、改善生活质量和认知功能提供一种有前景的治疗选择。尽管样本量小且存在严重不良事件，但这些发现值得用更大的队列进行进一步研究，以证实这些趋势并优化治疗方案。
