Modulating brain regions to treat bladder issues in multiple sclerosis

A Randomized, Sham-Controlled Clinical Trial Evaluating Individualized Neuromodulation of Cortical Regions Involved in Neurogenic Overactive Bladder in Multiple Sclerosis

This study is testing whether a new brain stimulation technique can help women with multiple sclerosis who have bladder problems feel better by focusing on the brain instead of just the bladder.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: The Methodist Hospital Research Institute (other)
• Drugs / interventions: radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06072703 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of repetitive transcranial magnetic stimulation (rTMS) to target brain regions involved in neurogenic overactive bladder (NOAB) in women with multiple sclerosis (MS). The study aims to shift the management of NOAB from a bladder-centric approach to a focus on brain restoration, utilizing noninvasive brain stimulation to improve urinary symptoms such as frequency and urgency. It is a randomized, double-blind, sham-controlled trial with an optional open-label extension phase, designed to evaluate the effectiveness of rTMS in enhancing brain connectivity and alleviating bladder dysfunction. Preliminary data suggest promising improvements in bladder symptoms without adverse effects.

Who should consider this trial

Good fit: Ideal candidates for this study are adult women aged 18 and older with clinically stable multiple sclerosis and symptoms of neurogenic lower urinary tract dysfunction.

Not a fit: Patients who are pregnant, have a history of seizure disorders, or have specific urodynamic findings such as bladder outlet obstruction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive and more effective treatment option for women with neurogenic bladder issues related to multiple sclerosis.

How similar studies have performed: While this approach is novel, preliminary data from related studies suggest potential success in improving bladder symptoms through brain modulation techniques.

Eligibility criteria

Inclusion Criteria:

* Adult women (≥ 18 years of age)
* Clinically stable MS defined as ExpandedDisability Status Score (EDSS) ≤ 7.5without exacerbation worsening in the preceding 6 months prior to study entry
* Neurogenic Lower Urinary Tract Dysfunction symptoms ≥ 3 months with NBSS total ≥ 15
* Individuals with Montreal Cognitive Assessment (MoCA) score \>10 will be eligible
* At least one bladder storage symptoms (e.g., urinary frequency, urinary urgency, nocturia with or without incontinence) indicated by OAB -AT≥ 8
* Individuals with active urinary tract infection (UTI) will be treated and will be enrolled after negative urinalysis

Exclusion Criteria:

* Pregnant/planning to become pregnant or nursing
* Urodynamic findings of bladder outlet obstruction
* Baclofen or other intrathecal pumps, Pacemakers.
* History of seizure disorder (SZ), immediate family of SZ disorder, in addition to individuals who are taking any medications such as (bupropion) Wellbutrin or substances (ex: heavy alcohol use) that would lower seizure threshold will be excluded.
* History of bipolar disorder, or individuals who are taking medications that can exacerbate the condition such as tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin-nor-epinephrine reuptake inhibitors, anti-psychotics, lithium, bupropion (Wellbutrin) and antihistamines will be excluded.
* All intracranial lesions and hemorrhagic stroke will be excluded
* History of moderate to severe heart disease or unstable angina
* History of Autonomic Dysreflexia
* History of interstitial cystitis, pelvic radiation
* Intra-detrusor botulinumtoxinA (BTX-A) injection over the past 6 months
* Incarcerated patients will be excluded.
* Active sacral nerve stimulation (SNS) device or any other spinal stimulators
* Indwelling urethral or suprapubic catheter

Where this trial is running

Houston, Texas

• Houston Methodist Hospital — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Rose Khavari, MD — The Methodist Hospital Research Institute
• Study coordinator: Rose Khavari, MD

Conditions: Neurogenic Bladder, Multiple Sclerosis, Overactive Bladder, Neurogenic bladder, Functional Neuroimaging, repetitive Transcranial Magnetic Stimulation, Neuromodulation