Department of Clinical Research Management, West China Hospital, Sichuan University, Chengdu, 610044, China.
Department of Neurology, West China Hospital, Joint Research Institution of Altitude Health, Sichuan University, Chengdu, 610044, China.
BMC Neurol. 2023 Jul 27;23(1):282. doi: 10.1186/s12883-023-03317-0.
A significant proportion of patients with epilepsy have an unknown etiology and lack effective targeted therapeutic drugs. Patent Foramen Ovale (PFO) induces hypoxia and microembolism, leading to cerebral neurological dysfunction and increased epilepsy risk. This study aims to assess the efficacy and safety of PFO closure for relieving epileptic seizures in patients with refractory epilepsy associated with PFO.
METHODS/DESIGN: Recruitment takes place at the West China Hospital of Sichuan University, China, for an open-label, randomized controlled clinical trial. The trial will include 110 patients with refractory epilepsy and PFO. Disease diagnoses will conform to the diagnostic criteria of the International League Against Epilepsy (ILAE) for refractory epilepsy and the American Society of Echocardiography (ASE) for PFO. Refractory epilepsy and high-grade right-to-left shunt (RLS) of the PFO will be further diagnosed using 24-hour video electroencephalogram and transthoracic echocardiography with contrast injection, respectively. Eligible participants require a secondary or higher volume of RLS.
Chinese Clinical Trial Registry (ChiCTR2200065681). Registered on November 11, 2022.
相当比例的癫痫患者病因不明，缺乏有效的靶向治疗药物。卵圆孔未闭（PFO）可导致缺氧和微栓塞，引起脑神经系统功能障碍和癫痫风险增加。本研究旨在评估 PFO 封堵术治疗伴有 PFO 的耐药性癫痫患者癫痫发作的疗效和安全性。
方法/设计：本试验在中国四川大学华西医院进行，为开放标签、随机对照临床试验。试验将纳入 110 例耐药性癫痫合并 PFO 的患者。疾病诊断符合国际抗癫痫联盟（ILAE）耐药性癫痫的诊断标准和美国超声心动图学会（ASE）PFO 的诊断标准。耐药性癫痫和 PFO 的高级右向左分流（RLS）将分别采用 24 小时视频脑电图和经胸超声心动图结合对比剂注射进一步诊断。合格的参与者需要存在二级或更高等级的 RLS。
中国临床试验注册中心（ChiCTR2200065681）。注册于 2022 年 11 月 11 日。
