Modulating brain regions to treat bladder issues in multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: rkhavari@houstonmethodist.org
• Phone: 7137030660

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.