Department of Pediatrics, Atrium Health-Levine Children's Hospital, Charlotte, North Carolina; Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, North Carolina.
Section of Neurology, Department of Pediatrics, University of Colorado School of Medicine, Children's Hospital Colorado, Aurora, Colorado.
Pediatr Neurol. 2023 Jun;143:106-112. doi: 10.1016/j.pediatrneurol.2023.03.001. Epub 2023 Mar 10.
Responsive neurostimulation (RNS), a closed-loop intracranial electrical stimulation system, is a palliative surgical option for patients with drug-resistant epilepsy (DRE). RNS is approved by the US Food and Drug Administration for patients aged ≥18 years with pharmacoresistant partial seizures. The published experience of RNS in children is limited.
This is a combined prospective and retrospective study of patients aged ≤18 years undergoing RNS placement. Patients were identified from the multicenter Pediatric Epilepsy Research Consortium Surgery Registry from January 2018 to December 2021, and additional data relevant to this study were retrospectively collected and analyzed.
Fifty-six patients received RNS during the study period. The mean age at implantation was 14.9 years; the mean duration of epilepsy, 8.1 years; and the mean number of previously trialed antiseizure medications, 4.2. Five patients (9%) previously trialed dietary therapy, and 19 patients (34%) underwent prior surgery. Most patients (70%) underwent invasive electroencephalography evaluation before RNS implantation. Complications occurred in three patients (5.3%) including malpositioned leads or transient weakness. Follow-up (mean 11.7 months) was available for 55 patients (one lost), and four were seizure-free with RNS off. Outcome analysis of stimulation efficacy was available for 51 patients: 33 patients (65%) were responders (≥50% reduction in seizure frequency), including five patients (10%) who were seizure free at follow-up.
For young patients with focal DRE who are not candidates for surgical resection, neuromodulation should be considered. Although RNS is off-label for patients aged <18 years, this multicenter study suggests that it is a safe and effective palliative option for children with focal DRE.
反应性神经刺激（RNS）是一种闭环颅内电刺激系统，是耐药性癫痫（DRE）患者的一种姑息性手术选择。RNS 已获得美国食品和药物管理局批准，用于年龄≥18 岁、药物难治性部分性发作的患者。RNS 在儿童中的应用经验有限。
这是一项对 2018 年 1 月至 2021 年 12 月期间接受 RNS 植入术的≤18 岁患者进行的前瞻性和回顾性联合研究。从多中心儿科癫痫研究联合会手术登记处确定患者，并回顾性收集和分析与本研究相关的其他数据。
研究期间，56 例患者接受 RNS 治疗。植入时的平均年龄为 14.9 岁；癫痫的平均病程为 8.1 年；平均尝试过的抗癫痫药物为 4.2 种。5 例患者（9%）曾尝试过饮食疗法，19 例患者（34%）曾接受过手术。大多数患者（70%）在 RNS 植入前接受了有创性脑电图评估。3 例患者（5.3%）出现并发症，包括导线位置不当或短暂无力。55 例患者（1 例失访）可获得随访（平均 11.7 个月），其中 4 例在 RNS 关闭时无癫痫发作。对 51 例患者进行刺激疗效分析：33 例患者（65%）为反应者（发作频率减少≥50%），其中 5 例（10%）在随访时无癫痫发作。
对于不适合手术切除的局灶性 DRE 年轻患者，应考虑神经调节。尽管 RNS 不适用于年龄<18 岁的患者，但这项多中心研究表明，它是局灶性 DRE 儿童的一种安全有效的姑息治疗选择。
