Neurogenic Bladder study: Magstim Rapid2 System
Official title Neuromodulating Cortical Regions Involved in Neurogenic Bladder in MS
ClinicalTrials.gov ID: NCT06072703
What this study is testing
- What it's testing
- This study aims to find out if a specific type of brain stimulation can reduce bladder problems like frequent urination and urgency in people with multiple sclerosis.
- Who it's for
- The study is looking for women with multiple sclerosis who experience bladder symptoms such as needing to go often or leaking urine.
- What's involved
- Participants will have a brain scan to map their brain, then receive 10 sessions of a painless magnetic treatment on the head. Some people will get the real treatment, while others will get a fake version to compare results.
- Time commitment
- The study takes about 4 to 5 months to finish, including the treatment sessions and follow-up visits.
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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
You likely can't join if
- 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)...
- History of bipolar disorder, or individuals who are taking medications that can exacerbate the condition such as tricyclic antidepressants, selective...
- All intracranial lesions and hemorrhagic stroke will be excluded
See the full eligibility 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.