Reducing pain by improving brain and muscle activity with motor cortical neuromodulation in women with interstitial cystitis/bladder pain syndrome: a study protocol for a randomized controlled trial

IF 2 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Trials Pub Date : 2024-09-12 DOI:10.1186/s13063-024-08450-w

Eileen V. Johnson, Molly Bachmann, Moheb S. Yani, Sandrah P. Eckel, Giselle I. Garcia, Larissa V. Rodriguez, Jason J. Kutch

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引用次数: 0

Abstract

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain condition creating a wide range of urologic and pain symptoms. There is currently limited evidence to understand the mechanisms of IC/BPS. There have been recent studies suggesting that altered function in brain motor areas, particularly the supplementary motor cortex (SMA), relates to altered bladder sensorimotor control and may play an important role in IC/BPS. This study aims to provide evidence that non-invasive stimulation targeting the motor cortex may help reduce IC/BPS pain, as well as better understand the neural mechanism by which this stimulation targets neuromuscular dysfunction. This study is a two-group quadruple-blinded randomized controlled trial (RCT) of active vs. sham repetitive transmagnetic stimulation (rTMS). In addition, our study will also include functional magnetic resonance imaging (fMRI), pelvic floor electromyography (EMG), pelvic exam, and outcome measures and questionnaires to further study outcomes. All aspects of the study were approved by the Institutional Review Board of the University of Southern California (protocol HS-20–01021). All participants provided informed consent by the research coordinator/assistants. The results will be submitted for publication in peer-reviewed journals and disseminated at scientific conferences. ClinicalTrials.gov NCT04734847. Registered on February 1, 2021.

查看原文本刊更多论文

通过运动皮层神经调节改善间质性膀胱炎/膀胱疼痛综合征女性患者的大脑和肌肉活动来减轻疼痛：随机对照试验的研究方案

间质性膀胱炎/膀胱疼痛综合征（IC/BPS）是一种慢性疼痛疾病，可引起多种泌尿系统和疼痛症状。目前，了解间质性膀胱炎/膀胱疼痛综合症发病机制的证据有限。最近有研究表明，大脑运动区（尤其是辅助运动皮层（SMA））的功能改变与膀胱感觉运动控制的改变有关，可能在 IC/BPS 中扮演重要角色。本研究旨在提供证据，证明针对运动皮层的非侵入性刺激可能有助于减轻 IC/BPS 疼痛，同时更好地了解这种刺激针对神经肌肉功能障碍的神经机制。本研究是一项两组四盲随机对照试验（RCT），分别为主动与假性重复经磁刺激（rTMS）。此外，我们的研究还将包括功能磁共振成像（fMRI）、盆底肌电图（EMG）、盆腔检查、结果测量和问卷调查，以进一步研究结果。该研究的所有方面均已获得南加州大学机构审查委员会的批准（协议 HS-20-01021）。所有参与者均由研究协调员/助理出具知情同意书。研究结果将在同行评审期刊上发表，并在科学会议上传播。ClinicalTrials.gov NCT04734847。注册日期为 2021 年 2 月 1 日。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Trials 医学-医学：研究与实验

CiteScore

3.80

自引率

4.00%

发文量

966

审稿时长

6 months

期刊介绍： Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.