Therapeutic effects of non-invasive, individualized, transcranial neuromodulation treatment for voiding dysfunction in multiple sclerosis patients: study protocol for a pilot clinical trial.
Therapeutic effects of non-invasive, individualized, transcranial neuromodulation treatment for voiding dysfunction in multiple sclerosis patients: study protocol for a pilot clinical trial.
复制标题
DOI：
10.1186/s40814-021-00825-z
复制
发表时间：
2021-03-24
影响因子：
1.7
通讯作者：
Khavari R
中科院分区：
文献类型：
--
作者：
Tran K;Shi Z;Karmonik C;John B;Rajab H;Helekar SA;Boone T;Khavari R
排尿功能障碍（VD）是多发性硬化（MS）患者常见的神经源性下尿路功能障碍（NLUTD）。目前，MS患者中VD和尿潴留的唯一有效管理是导管插入术，这促使我们寻找膀胱以外的新治疗选择，例如脑。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，可同时调节多个皮质区域，增强或减弱这些区域之间的功能连接强度。本初步临床试验的目的是通过研究TRPMS在女性MS患者排尿开始期间调节脑区域和缓解VD的治疗效果，评价TRPMS试验解决MS患者下尿路症状的可行性。本研究将招募10例VD成年女性MS患者（定义为排尿后残余尿量/膀胱容量（%PVR/BC）≥ 40%或利物浦列线图百分位数< 10%）。将在基线和治疗后同时进行尿动力学和功能性MRI评价，并重复膀胱充盈/排空任务3 - 4次。将在每例患者的基线解剖和功能MRI扫描上识别预定的感兴趣区域及其排尿开始时的血氧水平依赖性（BOLD）激活，对应于微刺激器放置在其个性化TRPMS治疗帽上，以刺激或抑制这些区域。患者将接受10次40分钟的治疗。还将在基线和治疗后收集非仪器化尿流和经验证的问卷，以评价临床改善。尽管中枢神经系统在排尿控制中起着至关重要的作用，并且对MS敏感，但目前还没有针对参与正常膀胱功能的脑中心的排尿功能障碍的治疗方法。据我们所知，这项试验将是第一个考虑非侵入性和个体化皮质调节治疗MS患者VD的人类试验。本研究的结果将更好地了解神经源性膀胱的大脑控制，并为未来MS患者VD和更大神经源性人群中其他NLUTD的潜在替代疗法奠定基础。本试验已在ClinicalTrials.Gov注册（NCT 03574610，2018年7月2日）。和休斯顿卫理公会研究所IRB（PRO 00019329）
Voiding dysfunction (VD) is a common neurogenic lower urinary tract dysfunction (NLUTD) in multiple sclerosis (MS) patients. Currently, the only effective management for VD and urinary retention in MS patients is catheterization, prompting us to look for novel therapeutic options beyond the bladder, such as the brain. Transcranial rotating permanent magnet stimulator (TRPMS) is a non-invasive, portable, multifocal neuromodulator that simultaneously modulates multiple cortical regions, enhancing or attenuating strengths of functional connections between these regions. The objective of this pilot clinical trial is to evaluate the feasibility of a TRPMS trial to address lower urinary tract symptoms in MS patients, through investigating the therapeutic effects of TRPMS in modulating brain regions during voiding initiation and mitigating VD in female MS individuals. Ten adult female MS patients with VD (defined as having %post-void residual/bladder capacity (%PVR/BC) ≥ 40% or Liverpool nomogram percentile < 10%) will be recruited for this study. Concurrent urodynamic and functional MRI evaluation with a bladder filling/emptying task repeated three to four times will be performed at baseline and post-treatment. Predetermined regions of interest and their blood-oxygen-level-dependent (BOLD) activation at voiding initiation will be identified on each patient’s baseline anatomical and functional MRI scan, corresponding to the microstimulators placement on their individualized TRPMS treatment cap to either stimulate or inhibit these regions. Patients will receive 10 40-min treatment sessions. Non-instrumented uroflow and validated questionnaires will also be collected at baseline and post-treatment to evaluate clinical improvement. Despite the crucial role of the central nervous system in urinary control and its sensitivity to MS, there has been no treatment for urinary dysfunction targeting the brain centers that are involved in proper bladder function. This trial, to our knowledge, will be the first of its kind in humans to consider non-invasive and individualized cortical modulation for treating VD in MS patients. Results from this study will provide a better understanding of the brain control of neurogenic bladders and lay the foundation for a potential alternative therapy for VD in MS patients and other NLUTD in a larger neurogenic population in the future. This trial is registered at ClinicalTrials.Gov (NCT03574610, 2 July 2018.) and Houston Methodist Research Institute IRB (PRO00019329)
登录
查看更多内容
影响因子：
14.5
作者：
Blok, BFM;Sturms, LM;Holstege, G
通讯作者：
Holstege, G
影响因子：
6.6
作者：
Schrum, A.;Wolff, S.;Kuhtz-Buschbeck, J. P.
通讯作者：
Kuhtz-Buschbeck, J. P.
影响因子：
4.5
作者：
Kavia, Rajesh;DasGupta, Ranan;Griffiths, Derek
通讯作者：
Griffiths, Derek
影响因子：
2
作者：
Stoffel JT
通讯作者：
Stoffel JT
DOI：
10.1016/j.juro.2014.04.090
发表时间：
2014-10
期刊：
The Journal of urology
影响因子：
--
作者：
Shy M;Fung S;Boone TB;Karmonik C;Fletcher SG;Khavari R
通讯作者：
Khavari R