Neuromodulating Cortical Regions for Neurogenic Bladder in MS

This study is exploring a new way to manage neurogenic overactive bladder (NOAB) in women with multiple sclerosis (MS). NOAB causes frequent urination, urgency, and incontinence. Instead of focusing on the bladder, this study uses a device called the Magstim Rapid2 System to stimulate specific areas of the brain. This stimulation, called repetitive transcranial magnetic stimulation (rTMS), aims to improve how the brain controls bladder function. You may be eligible if you are an adult woman (18 or older) with stable MS and have experienced NOAB symptoms for at least three months. The study will measure changes in your bladder symptoms using questionnaires and a bladder diary over three months after treatment. The current status of the study is unclear, and it plans to enroll 29 participants.

Study design
This is an interventional study with a planned enrollment of 29 adult women. It is not specified if the study is randomized or blinded.
What's involved
You would complete questionnaires and a 2-day bladder diary at the start of the study, and then again 1 week, 1 month, and 3 months after receiving rTMS treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for three months after receiving rTMS treatment.

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NCT06072703

Neuromodulating Cortical Regions Involved in Neurogenic Bladder in MS

Recruiting
NAAges 18+InterventionalTreatment
The Methodist Hospital Research Institute
~29 participants
Updated 2026-03-23 on ClinicalTrials.gov
What's tested:Magstim Rapid2 System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in subjective clinical outcomes following treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire
Measured over Baseline, 1 week after, 1 month after and 3 months after rTMS treatment
+1 more outcome measured
Neurogenic Bladder
Multiple Sclerosis
Overactive Bladder
1 sites across 1 states
Texas1
  • Rose Khavari, MD · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute

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Eligibility criteria

Inclusion

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

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
  • Changes in subjective clinical outcomes following treatment - Neurogenic Bladder Symptom Score (NBSS) QuestionnaireBaseline, 1 week after, 1 month after and 3 months after rTMS treatment

    The subjective clinical assessment includes changes in validated questionnaires. This assessment has 24 questions that measure bladder symptoms across 3 different domains: incontinence (score range: 0-29), storage and voiding (score range: 0-22), and consequences (score range: 0-23); the highest score is associated with worse symptoms. The last question focuses on quality of life scored from 0 (pleased) to 4 (unhappy). The investigators report raw scores here for all domains and QoL.

  • Changes on patient reported outcomes following treatment - 2 day bladder diaryBaseline, 1 week after, 1 month after and 3 months after rTMS treatment

    Here the investigators evaluate changes on the number of times that symptoms associated with neurogenic overactive bladder occur in a 24hr period after rTMS treatment. Reported outcomes by patients include the number of times the following occur: voids, nocturia, severe urgency episodes, and urgency urinary incontinence episodes.