A Randomized, Sham-Controlled Clinical Trial Evaluating Individualized Neuromodulation of Cortical Regions Involved in Neurogenic Overactive Bladder in Multiple Sclerosis
New brain stimulation trial for Multiple Sclerosis patients with bladder issues
Plain English Summary
Neuromodulating Cortical Regions Involved in Neurogenic Bladder in MS is a Not Applicable clinical trial sponsored by The Methodist Hospital Research Institute studying Neurogenic Bladder, Multiple Sclerosis, Overactive Bladder. This trial tests a non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) to improve bladder control in women with Multiple Sclerosis (MS). It is for adult women with MS who experience frequent urination, urgency, or incontinence due to nerve damage affecting their bladder. Participants will receive either real or sham (placebo) rTMS treatment targeting specific brain areas, with regular assessments of bladder symptoms and brain activity. Current treatments for neurogenic overactive bladder in MS often have limited success and side effects, highlighting the need for new approaches like this. The trial aims to enroll 29 participants.
Official Summary
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. Al
Who Can Participate
Here is what you need to know about eligibility for this trial. Adult women aged 18 and older with a confirmed diagnosis of MS and bladder control problems. Patients must have stable MS and a certain level of bladder symptom severity. Individuals with a history of seizures, bipolar disorder, certain heart conditions, or those who are pregnant or nursing cannot participate. Active urinary tract infections must be treated before enrollment, and certain bladder outlet obstructions or previous bladder treatments may exclude participation. This trial is studying Neurogenic Bladder, Multiple Sclerosis, Overactive Bladder, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcomes measure how much the brain stimulation improves bladder symptoms like frequency and urgency, as reported by patients using symptom scores and bladder diaries. The specific primary outcome measures are: Changes in subjective clinical outcomes following treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire (Baseline, 1 week after, 1 month after and 3 months after rTMS treatment); Changes on patient reported outcomes following treatment - 2 day bladder diary (Baseline, 1 week after, 1 month after and 3 months after rTMS treatment). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses a significant unmet need for effective and less invasive treatments for neurogenic overactive bladder, a common and distressing symptom in Multiple Sclerosis patients. This research targets Neurogenic Bladder, Multiple Sclerosis, Overactive Bladder, where improved treatment options are needed.
Investor Insight
This trial explores a novel, non-invasive neuromodulation approach for a common MS complication, potentially opening a new therapeutic avenue with a large patient population if successful.
Is This Trial Right for Me?
Ask your doctor if this trial is a good fit for your specific MS and bladder symptoms. Participation involves regular visits for brain stimulation sessions and symptom assessments over several months. You will undergo screening, receive treatment, and have your progress monitored through questionnaires and potentially brain imaging. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: TRIPLE
- Enrollment: 29 participants
Interventions
- DEVICE: Magstim Rapid2 System — The Magstim Rapid2 system is the most commonly used magnetic stimulation system for rTMS clinical studies and therapeutic investigations, capable of selectively inducing, modulating or suppressing neuronal activity. This rTMS device will be used along with the D70 Alpha Coil package, which includes an active coil ideal for focal rTMS and a sham coil, The placebo coil looks identical to its active version and replicates pulse noise without producing the magnetic field necessary to modulate cortic
Primary Outcomes
- Changes in subjective clinical outcomes following treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire (Baseline, 1 week after, 1 month after and 3 months after rTMS treatment)
- Changes on patient reported outcomes following treatment - 2 day bladder diary (Baseline, 1 week after, 1 month after and 3 months after rTMS treatment)
Secondary Outcomes
- Changes in brain activation patterns following rTMS treatment - functional MRI imaging (Baseline and 1 week after rTMS treatment)
- Changes in objective clinical outcomes following treatment - Bladder Capacity (Baseline, 1 week after, 1 month after and 3 months after rTMS treatment)
- Changes in %Post-Void Residual/Bladder Capacity (PVR/BC) following treatment (Baseline, 1 week after, 1 month after and 3 months after rTMS treatment)
Full 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
Trial Locations
- Houston Methodist Hospital, Houston, Texas, United States
Frequently Asked Questions
What is clinical trial NCT06072703?
NCT06072703 is a Not Applicable INTERVENTIONAL study titled "Neuromodulating Cortical Regions Involved in Neurogenic Bladder in MS." It is currently recruiting and is sponsored by The Methodist Hospital Research Institute. The trial targets enrollment of 29 participants.
What conditions does NCT06072703 study?
This trial investigates treatments for Neurogenic Bladder, Multiple Sclerosis, Overactive Bladder. The primary condition under study is Neurogenic Bladder.
What treatments are being tested in NCT06072703?
The interventions being studied include: Magstim Rapid2 System (DEVICE). The Magstim Rapid2 system is the most commonly used magnetic stimulation system for rTMS clinical studies and therapeutic investigations, capable of selectively inducing, modulating or suppressing neuronal activity. This rTMS device will be used along with the D70 Alpha Coil package, which includes an active coil ideal for focal rTMS and a sham coil, The placebo coil looks identical to its active version and replicates pulse noise without producing the magnetic field necessary to modulate cortic
What does Not Applicable mean for NCT06072703?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06072703?
This trial is currently "Recruiting." It started on 2023-10-30. The estimated completion date is 2027-12-31.
Who is sponsoring NCT06072703?
NCT06072703 is sponsored by The Methodist Hospital Research Institute. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06072703?
The trial aims to enroll 29 participants. The trial is currently recruiting and accepting new participants.
How is NCT06072703 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs triple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06072703?
The primary outcome measures are: Changes in subjective clinical outcomes following treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire (Baseline, 1 week after, 1 month after and 3 months after rTMS treatment); Changes on patient reported outcomes following treatment - 2 day bladder diary (Baseline, 1 week after, 1 month after and 3 months after rTMS treatment). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06072703 being conducted?
This trial is being conducted at 1 site, including Houston, Texas (United States).
Where can I find official information about NCT06072703?
The official record for NCT06072703 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06072703. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06072703 testing in simple terms?
This trial tests a non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) to improve bladder control in women with Multiple Sclerosis (MS). It is for adult women with MS who experience frequent urination, urgency, or incontinence due to nerve damage affecting their bladder.
Why is this trial significant?
This trial addresses a significant unmet need for effective and less invasive treatments for neurogenic overactive bladder, a common and distressing symptom in Multiple Sclerosis patients.
What are the potential risks of participating in NCT06072703?
The most common side effects of rTMS are mild and temporary, such as headache or discomfort at the stimulation site. There is a small risk of seizures, although this is rare with the specific type of stimulation used. Some patients may not experience any improvement in their bladder symptoms. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06072703?
Ask your doctor if this trial is a good fit for your specific MS and bladder symptoms. Participation involves regular visits for brain stimulation sessions and symptom assessments over several months. You will undergo screening, receive treatment, and have your progress monitored through questionnaires and potentially brain imaging. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06072703 signal from an investment perspective?
This trial explores a novel, non-invasive neuromodulation approach for a common MS complication, potentially opening a new therapeutic avenue with a large patient population if successful. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive either real or sham (placebo) rTMS treatment targeting specific brain areas, with regular assessments of bladder symptoms and brain activity. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.