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Neuromodulation
Non-Invasive Brain Stimulation for Neurogenic Bladder in MS (MSBLADDER Trial)
N/A
Recruiting
Led By Rose Khavari, MD
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least one bladder storage symptom (e.g., urinary frequency, urinary urgency, nocturia with or without incontinence) indicated by OAB-AT≥ 8
Adult women (≥ 18 years of age)
Must not have
All intracranial lesions and hemorrhagic stroke will be excluded
History of moderate to severe heart disease or unstable angina
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week after, 1 month after and 3 months after rtms treatment
Summary
This trial is studying the effects of a non-invasive brain stimulation therapy (rTMS) on overactive bladder symptoms in people with multiple sclerosis (MS). The results of this study could provide a promising new approach to MS bladder control.
Who is the study for?
This trial is for adult women with Multiple Sclerosis (MS) who have stable MS symptoms and experience overactive bladder issues. They must not be pregnant, planning to become pregnant, or nursing, and should not have a history of certain mental health conditions or be on medications that could worsen these conditions.
What is being tested?
The study tests the effects of repetitive Transcranial Magnetic Stimulation (rTMS), a noninvasive brain therapy aimed at improving bladder control in women with MS. Participants will undergo treatment sessions after an initial screening and functional MRI scan to locate target brain regions.
What are the potential side effects?
Preliminary data suggests no treatment-related adverse effects from rTMS. However, as it's a noninvasive procedure modulating brain activity, potential side effects might include mild headaches or scalp discomfort during application.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience frequent urination, urgency, or need to urinate at night.
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I am a woman aged 18 or older.
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I had a UTI, but it's treated and my latest urine test was clear.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any brain lesions or history of bleeding in the brain.
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I have a history of serious heart disease or unstable chest pain.
Select...
I have had interstitial cystitis or pelvic radiation.
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I do not have bipolar disorder nor am I taking any medications that could worsen it.
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I have received a Botox injection in my bladder muscle within the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 week after, 1 month after and 3 months after rtms treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week after, 1 month after and 3 months after rtms treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in subjective clinical outcomes following treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire
Changes on patient reported outcomes following treatment - 2 day bladder diary
Secondary study objectives
Changes in %Post-Void Residual/Bladder Capacity (PVR/BC) following treatment
Changes in brain activation patterns following rTMS treatment - functional MRI imaging
Changes in objective clinical outcomes following treatment - Bladder Capacity
Other study objectives
Changes in subjective clinical outcomes following treatment - American Urological Association Symptom Score (AUASS) Questionnaire
Changes in subjective clinical outcomes following treatment - Incontinence Impact Questionnaire Short Form (IIQ-7)
Changes in subjective clinical outcomes following treatment - Overactive Bladder (OAB) Awareness Tool
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active rTMSActive Control1 Intervention
1 Hz (LF) and 10 Hz (HF) rTMS stimulation will be delivered at 90% of the resting motor threshold for 40 min each week day for two weeks.
Group II: Sham rTMSPlacebo Group1 Intervention
Low-frequency (1Hz) active rTMS stimulation will be delivered with an inert "sham" stimulation coil for 40 min each week day for two weeks.
Find a Location
Who is running the clinical trial?
The Methodist Hospital Research InstituteLead Sponsor
287 Previous Clinical Trials
81,751 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
49 Patients Enrolled for Multiple Sclerosis
Rose Khavari, MDPrincipal InvestigatorThe Methodist Hospital Research Institute
9 Previous Clinical Trials
497 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
39 Patients Enrolled for Multiple Sclerosis