NCT06072703: MSBLADDER

Neuromodulating Cortical Regions Involved in Neurogenic Bladder in MS

Recruiting now NA Last updated 23 March 2026

What this trial tests

NA trial testing Magstim Rapid2 System in Neurogenic Bladder in 29 participants. Currently enrolling.

Timeline

30 October 2023

Primary endpoint
31 December 2027

31 December 2027

Quick facts

Lead sponsor	The Methodist Hospital Research Institute
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	29
Start date	30 October 2023
Primary completion	31 December 2027
Estimated completion	31 December 2027
Sites	1 location across United States

Drugs / interventions tested

• Magstim Rapid2 System

Conditions studied

• Neurogenic Bladder — all drugs for Neurogenic Bladder →
• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Overactive Bladder — all drugs for Overactive Bladder →

Sponsor

The Methodist Hospital Research Institute

Who can join

18 and older, female only, with Neurogenic Bladder or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Neurogenic overactive bladder (NOAB), characterized by urinary frequency, urgency or urgency incontinence symptoms occurring during the storage phase of the bladder, is the most common urinary complaint in multiple sclerosis (MS). Current management options for NOAB in MS have limited efficacy and considerable adverse effects, which underscores the significance of this study and highlights the need for better, less invasive therapies. This novel study investigates brain therapeutic targets that could shift the focus of NOAB management in MS from a bladder-centric focus to brain restoration; specifically modulating the brain regions identified in the prior functional magnetic resonance imagining studies. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive brain stimulation that can modulate neurons (excite or inhibit) to improve the connectivity of the regions of interest (ROI). The preliminary data demonstrate, for the first time, significant improvement in bladder symptoms in ten women with MS who have voiding dysfunction following multifocal transcranial magnetic stimulation without any treatment-related adverse effects.

This randomized double-blind, sham-controlled single center clinical trial with an optional open-label extension (OLE) phase is designed to evaluate the effects of targeted rTMS in women with MS and NOAB by investigating restorative reorganization of brain function The main purpose of this study is to determine the effects of individualized repetitive Transcranial Magnetic Stimulation (rTMS) for improving overactive bladder symptoms such as urinary frequency and urgency with or without incontinence in individuals with multiple sclerosis (MS). Patients will undergo initial screening that includes a demographics information, physical exam, past medical and surgical history, medication list, urine pregnancy test (female subjects with childbearing potential), and completion of questionnaires to confirm the eligibility of patients. All eligible patients will be required to complete a functional MRI scan followed by locating the regions of interest through neural navigation system and finally receiving 10 treatment sessions.

Since this is a randomized trial, some patients will receive active treatment/ therapy sessions while others will only receive sham or placebo treatments. The total duration to complete all treatment sessions and follow up visits is approximately 4-5 months.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluating noninvasive brain stimulation to treat overactive bladder in individuals with multiple sclerosis: a randomized controlled trial protocol.
   Salazar BH, Hoffman KA, Lincoln JA, Karmonik C, et al · · 2024 · cited 3× · PMID 38273296 · DOI 10.1186/s12894-023-01358-8