Division of Adult Neurology, Department of Neurosciences, College of Medicine, Philippine General Hospital, University of the Philippines Manila, Manila, Philippines.
Division of Neurosurgery, Department of Neurosciences, College of Medicine and Philippine General Hospital, University of the Philippines Manila, Manila, Philippines.
BMC Neurol. 2023 Aug 18;23(1):306. doi: 10.1186/s12883-023-03344-x.
Transcranial magnetic resonance-guided focused ultrasound (MRgFUS) is a noninvasive method for controlling tremor and has recently been used in patients with X-linked dystonia-parkinsonism (XDP). This study aims to determine the improvement in dystonia and parkinsonism in patients with XDP after MRgFUS pallidothalamic tractotomy. This prospective study will be conducted at the Philippine General Hospital, University of the Philippines Manila. The primary outcome measure is the change in the pre- and post-treatment XDP-Movement Disorder Society of the Philippines Scale scores. In addition, demographic and clinical data will be collected, including the Burke-Fahn-Marsden Dystonia Rating Scale, Part III of the Movement Disorder Society-Unified Parkinson's disease Rating Scale score, XDP clinical and functional stage, the five-level EuroQol five-dimensional questionnaire, Montreal Cognitive Assessment scores, MRgFUS treatment parameters, and adverse events. Patients will be assessed within 24 hours of treatment, then at 2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment. This protocol was approved by the University of the Philippines Manila Research Ethics Board (UPMREB 2022-0271-01). Data collection began in January 2023. This protocol has been registered with ClinicalTrials.gov: Trial Registration number: NCT05592028.
经颅磁共振引导聚焦超声(MRgFUS)是一种用于控制震颤的非侵入性方法,最近已用于 X 连锁肌张力障碍-帕金森病(XDP)患者。本研究旨在确定 MRgFUS 苍白球丘脑束切开术对 XDP 患者的肌张力障碍和帕金森病的改善情况。这项前瞻性研究将在菲律宾马尼拉的菲律宾总医院和菲律宾大学进行。主要的结局衡量标准是 XDP-Movement Disorder Society of the Philippines Scale 评分的治疗前后变化。此外,还将收集人口统计学和临床数据,包括 Burke-Fahn-Marsden 肌张力障碍评定量表、运动障碍协会统一帕金森病评定量表第三部分评分、XDP 临床和功能阶段、五维欧洲五维健康量表、蒙特利尔认知评估评分、MRgFUS 治疗参数和不良事件。患者将在治疗后 24 小时内进行评估,然后在治疗后 2 周、3 个月、6 个月、9 个月和 12 个月进行评估。该方案已获得菲律宾马尼拉大学伦理审查委员会(UPMREB 2022-0271-01)的批准。数据收集于 2023 年 1 月开始。该方案已在 ClinicalTrials.gov 注册:试验注册号:NCT05592028。