Scalia Gianluca, Alberio Nicola, Trombatore Pietro, Panebianco Mariangela, Razza Grazia, Galvano Gianluca, Nicoletti Giovanni Federico, Graziano Francesca
Unit of Neurosurgery, Department of Head and Neck Surgery, Garibaldi Hospital, 95124 Catania, Italy.
School of Medicine and Surgery, Kore University of Enna, 94100 Enna, Italy.
Brain Sci. 2025 May 16;15(5):508. doi: 10.3390/brainsci15050508.
Idiopathic normal pressure hydrocephalus (iNPH) is a progressive neurological disorder characterized by cognitive decline, gait disturbances, and urinary incontinence. Surgical interventions such as ventriculoperitoneal shunt (VPS) and endoscopic third ventriculostomy (ETV) are the primary treatment options. While VPS is the standard of care, ETV offers a minimally invasive alternative with potentially fewer complications. However, comparative evidence regarding their impact on cognitive, motor, and structural outcomes remains limited. This study, titled ENVENTOR-iNPH (endoscopic ventriculostomy versus shunt on neuropsychological and motor performance in patients with iNPH), aims to address this gap through a rigorously designed comparative protocol. This protocol is designed as a multicenter, randomized, controlled trial (ENVENTOR-iNPH) to compare the effects of ETV and VPS in patients diagnosed with iNPH. The study will enroll 100 patients aged 60 years or older, randomly assigned to undergo ETV (n = 50) or VPS (n = 50). Preoperative and postoperative evaluations will include comprehensive cognitive and motor assessments, standardized quality-of-life instruments, and advanced neuroimaging techniques such as MRI with flowmetry and diffusion tensor imaging (DTI). Functional outcomes will also be evaluated using navigated transcranial magnetic stimulation (nTMS) and wearable motion analysis systems. The objective of this study is to compare the efficacy and safety of ETV versus VPS in restoring cognitive and motor performance in patients with iNPH. Primary outcomes include cognitive and motor function improvements. Secondary endpoints are surgical complications, hospital stay duration, and changes in quality of life. Neuroimaging will assess changes in white matter integrity and cerebrospinal fluid dynamics, while nTMS will provide insights into neuroplasticity and motor pathway recovery. ETV is hypothesized to demonstrate clinical outcomes comparable or superior to VPS, particularly in terms of complication reduction and hospital recovery metrics. The ENVENTOR-iNPH protocol establishes the framework for a comprehensive, multicenter study comparing ETV and VPS in iNPH patients. The findings from this initial study will inform the design of larger-scale multicenter trials, guide clinical decision making, and potentially position ETV as a preferred treatment option for eligible patients.
特发性正常压力脑积水（iNPH）是一种进行性神经疾病，其特征为认知功能下降、步态障碍和尿失禁。手术干预措施，如脑室腹腔分流术（VPS）和内镜下第三脑室造瘘术（ETV）是主要的治疗选择。虽然VPS是标准治疗方法，但ETV提供了一种微创替代方案，且潜在并发症可能更少。然而，关于它们对认知、运动和结构结果影响的比较证据仍然有限。这项名为ENVENTOR-iNPH（内镜下脑室造瘘术与分流术对iNPH患者神经心理和运动表现的影响）的研究旨在通过严格设计的比较方案来填补这一空白。 该方案设计为一项多中心、随机对照试验（ENVENTOR-iNPH），以比较ETV和VPS对诊断为iNPH患者的影响。该研究将招募100名60岁及以上的患者，随机分配接受ETV（n = 50）或VPS（n = 50）。术前和术后评估将包括全面的认知和运动评估、标准化的生活质量工具以及先进的神经影像技术，如带有血流测量和扩散张量成像（DTI）的MRI。功能结果也将使用导航经颅磁刺激（nTMS）和可穿戴运动分析系统进行评估。本研究的目的是比较ETV与VPS在恢复iNPH患者认知和运动表现方面的疗效和安全性。主要结果包括认知和运动功能改善。次要终点是手术并发症、住院时间和生活质量变化。神经影像将评估白质完整性和脑脊液动力学的变化，而nTMS将提供有关神经可塑性和运动通路恢复的见解。假设ETV将显示出与VPS相当或更好的临床结果，特别是在减少并发症和住院恢复指标方面。 ENVENTOR-iNPH方案为一项比较iNPH患者中ETV和VPS的全面多中心研究建立了框架。这项初步研究的结果将为更大规模多中心试验的设计提供信息，指导临床决策，并可能将ETV定位为符合条件患者的首选治疗选择。
