NCT06072703 Neuromodulating Cortical Regions Involved in Neurogenic Bladder in MS
| NCT ID | NCT06072703 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Methodist Hospital Research Institute |
| Condition | Neurogenic Bladder |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2023-10-30 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 29 participants in total. It began in 2023-10-30 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
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
Contact & Investigator
Rose Khavari, MD
PRINCIPAL INVESTIGATOR
The Methodist Hospital Research Institute
Frequently Asked Questions
Who can join the NCT06072703 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Neurogenic Bladder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06072703 currently recruiting?
Yes, NCT06072703 is actively recruiting participants. Contact the research team at rkhavari@houstonmethodist.org for enrollment information.
Where is the NCT06072703 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06072703 clinical trial?
NCT06072703 is sponsored by The Methodist Hospital Research Institute. The principal investigator is Rose Khavari, MD at The Methodist Hospital Research Institute. The trial plans to enroll 29 participants.