Noninvasive, Individualized Cortical Modulation Using Transcranial Rotating Permanent Magnet Stimulator for Voiding Dysfunction in Women with Multiple Sclerosis: A Pilot Trial.

Noninvasive, Individualized Cortical Modulation Using Transcranial Rotating Permanent Magnet Stimulator for Voiding Dysfunction in Women with Multiple Sclerosis: A Pilot Trial.
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DOI:
10.1097/ju.0000000000002297
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发表时间:
2022-03
期刊:
影响因子:
6.6
通讯作者:
Boone, Timothy
Boone, Timothy
中科院分区:
医学1区
文献类型:
--
作者:
Khavari, Rose;Tran, Khue;Helekar, Santosh A.;Shi, Zhaoyue;Karmonik, Christof;Rajab, Hamida;John, Blessy;Jalali, Ali;Boone, Timothy

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排尿功能障碍(VD)导致尿潴留是多发性硬化(MS)患者常见的神经源性下尿路症状。目前,MS伴VD患者的唯一有效管理方法是导管插入术。经颅旋转永磁刺激器(TRPMS)是一种非侵入性、便携式、多灶性神经调节器,可同时调节多个皮层区域及其功能连接的强度。在这项初步试验(ClinicalTrials.gov标识符:NCT 03574610)中,我们研究了TRPMS在调节参与排尿启动的脑感兴趣区(ROI)以改善MS女性VD中的安全性和治疗效果。10名患有VD的MS女性(排尿后残留/膀胱容量%[%PVR/BC] ≥40%或在利物浦列线图的第10百分位数以下)在基线和治疗后接受了同时进行的功能性磁共振成像/尿动力学研究(fMRI/UDS),包括3个周期的膀胱充盈/排空。在患者的基线fMRI/UDS扫描上识别预定的ROI及其在排尿开始时的激活,对应于微刺激器的放置。患者连续接受10次40分钟的治疗。在基线和治疗后比较脑激活组分析、非仪器尿流和有效问卷。未报告治疗相关不良反应。治疗后,患者在已知参与健康受试者排尿开始的区域中显示出显著增加的激活。%PVR/BC显著降低。患者通过经验证的问卷报告膀胱排空症状显著改善。神经影像学和临床数据均表明,TRPMS有效且安全地调节了参与排尿周期排尿阶段的脑区,导致MS患者膀胱排空的临床改善。
Voiding dysfunction (VD) leading to urinary retention is a common neurogenic lower urinary tract symptom in patients with multiple sclerosis (MS). Currently, the only effective management for patients with MS with VD is catheterization. Transcranial Rotating Permanent Magnet Stimulator (TRPMS) is a noninvasive, portable, multifocal neuromodulator that simultaneously modulates multiple cortical regions and the strength of their functional connections. In this pilot trial (ClinicalTrials.gov Identifier: NCT03574610), we investigated the safety and therapeutic effects of TRPMS in modulating brain regions of interest (ROIs) engaged with voiding initiation to improve VD in MS women. Ten MS women with VD (having % post-void residual/bladder capacity [%PVR/BC] ≥40% or being in the lower 10th percentile of the Liverpool nomogram) underwent concurrent functional magnetic resonance imaging/urodynamic study (fMRI/UDS) with 3 cycles of bladder filling/emptying, at baseline and post-treatment. Predetermined ROIs and their activations at voiding initiation were identified on patients’ baseline fMRI/UDS scans, corresponding to microstimulator placement. Patients received 10 consecutive 40-minute treatment sessions. Brain activation group analysis, noninstrumented uroflow, and validated questionnaires were compared at baseline and post-treatment. No treatment-related adverse effects were reported. Post-treatment, patients showed significantly increased activation in regions known to be involved at voiding initiation in healthy subjects. %PVR/BC significantly decreased. Significant improvement of bladder emptying symptoms were reported by patients via validated questionnaires. Both neuroimaging and clinical data suggested TRPMS effectively and safely modulated brain regions that are involved in the voiding phase of the micturition cycle, leading to clinical improvements in bladder emptying in patients with MS.