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Neuromodulating Cortical Regions Involved in Neurogenic Bladder in MS

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Physical exams, Questionnaires, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether repeated magnetic pulses to the brain (rTMS) can improve bladder symptoms in adult women with multiple sclerosis (MS). These symptoms include needing to pee often or suddenly, with or without leaks. Participants receive 10 real or sham (inactive) treatment sessions, with treatment and follow-up lasting about 4–5 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older.
  • Stable MS with no worsening flare-ups in the past 6 months and an EDSS disability score of 7.5 or less.
  • Bladder symptoms caused by nerve problems for at least 3 months, with an NBSS bladder symptom score of at least 15.
  • A score above 10 on the MoCA test of memory and thinking.
  • At least one symptom: peeing often, a sudden need to pee, or waking at night to pee, with or without leaks. The OAB-AT bladder symptom score must be at least 8.
  • If you have a urinary tract infection, it must be treated and a urine test must be negative before you can join.

Who can't join

  • Pregnant, planning pregnancy, or breastfeeding.
  • A pacemaker; a baclofen or other spinal medicine pump; an active sacral nerve device or another spinal stimulator; or a bladder drainage tube left in place through the urine opening or belly.
  • A seizure disorder, an immediate family member with a seizure disorder, or medicines or substances that raise seizure risk, such as bupropion (Wellbutrin) or heavy alcohol use.
  • A history of bipolar disorder, or taking medicines listed as able to worsen it: tricyclic antidepressants, SSRIs, SNRIs, antipsychotics, lithium, bupropion (Wellbutrin), or antihistamines.
  • Any area of damaged or abnormal tissue inside the skull, or a stroke caused by bleeding.
  • A history of moderate to severe heart disease, unstable chest pain from heart disease, or autonomic dysreflexia (a sudden dangerous rise in blood pressure).
  • Tests showing blocked urine flow out of the bladder; a history of interstitial cystitis (a painful bladder condition) or radiation to the pelvis; or Botox injections into the bladder muscle in the past 6 months.
  • Currently in jail or prison.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

TX