Similarity of functional connectivity patterns in patients with multiple sclerosis who void spontaneously versus patients with voiding dysfunction.
Rose Khavari, Saba N Elias, Timothy Boone...
https://pubmed.ncbi.nlm.nih.gov/30311665Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID06072703
A Randomized, Sham-Controlled Trial of Personalized Brain Stimulation for Neurogenic Overactive Bladder in Women with Multiple Sclerosis
Led by The Methodist Hospital Research Institute · Updated on 2026-03-23
29
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Neurogenic overactive bladder (NOAB) is a common issue in women with multiple sclerosis (MS), causing symptoms like frequent urination, urgency, and incontinence during bladder storage. Current treatments often have limited success and side effects. This study explores a new approach that targets brain regions involved in bladder control using repetitive transcranial magnetic stimulation (rTMS), aiming to improve symptoms by restoring brain function rather than focusing only on the bladder itself. Participants will receive either active or sham rTMS treatment using the Magstim Rapid2 system, which delivers magnetic stimulation to specific brain regions identified by functional MRI and neural navigation. Treatment involves 10 sessions over two weeks, with daily 40-minute sessions of either low-frequency or high-frequency stimulation at 90% of resting motor threshold. After the initial trial period, participants may opt to join an open-label extension phase to continue receiving treatment. Throughout the study, women with MS will undergo screening, MRI scans, and detailed assessments including bladder diaries and symptom questionnaires before and after treatment. Researchers will monitor brain activity changes with functional MRI and track symptoms using the Neurogenic Bladder Symptom Score and bladder capacity measurements at multiple points up to three months post-treatment. The total participation time spans about 4 to 5 months, including follow-up visits to assess safety and long-term effects.
CONDITIONS
Brief Title
Neuromodulating Cortical Regions Involved in Neurogenic Bladder in MS
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Adult women (18 years or older)
- Clinically stable multiple sclerosis with no worsening in the past 6 months and EDSS score 7.5 or less
- Neurogenic lower urinary tract symptoms for at least 3 months with NBSS total score 15 or higher
- Montreal Cognitive Assessment (MoCA) score greater than 10
- At least one bladder storage symptom such as urinary frequency, urgency, or nocturia with or without incontinence indicated by OAB-AT 8 or higher
- Individuals with active urinary tract infection will be treated and can enroll after a negative urinalysis
You will not qualify if you...
- Pregnant, planning pregnancy, or nursing
- Bladder outlet obstruction detected by urodynamics
- Use of Baclofen or other intrathecal pumps, or presence of pacemakers
- History of seizure disorder, family history of seizures, or use of medications/substances that lower seizure threshold
- History of bipolar disorder or use of medications that may worsen it (e.g., certain antidepressants, antipsychotics, lithium, antihistamines)
- Presence of intracranial lesions or hemorrhagic stroke
- Moderate to severe heart disease or unstable angina
- History of autonomic dysreflexia
- History of interstitial cystitis or pelvic radiation
- Botulinum toxin injection in bladder within past 6 months
- Incarcerated individuals
- Active sacral nerve stimulation or other spinal stimulators
- Use of indwelling urethral or suprapubic catheter
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 2 weeks
Participants receive neuronavigated repetitive transcranial magnetic stimulation (rTMS) or sham stimulation to modulate brain regions involved in bladder function.
5 visits per week (in-person) for 2 weeks
Follow-up
Duration - 3 months
Participants are followed to assess clinical symptoms, brain imaging changes, and safety after treatment.
4 visits (1 week, 1 month, and 3 months after treatment plus baseline)
Trial Site Locations
Total: 1 location
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
R
Rose Khavari, MD
B
Betsy Salazar, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Higher Neural Correlates in Patients with Multiple Sclerosis and Neurogenic Overactive Bladder Following Treatment with Intradetrusor Injection of OnabotulinumtoxinA.
Rose Khavari, Saba N Elias, Rashmi Pande...
https://pubmed.ncbi.nlm.nih.gov/30076906Noninvasive, Individualized Cortical Modulation Using Transcranial Rotating Permanent Magnet Stimulator for Voiding Dysfunction in Women with Multiple Sclerosis: A Pilot Trial.
Rose Khavari, Khue Tran, Santosh A Helekar...
https://pubmed.ncbi.nlm.nih.gov/34694911Functional Magnetic Resonance Imaging with Concurrent Urodynamic Testing Identifies Brain Structures Involved in Micturition Cycle in Patients with Multiple Sclerosis.
Rose Khavari, Christof Karmonik, Michael Shy...
https://pubmed.ncbi.nlm.nih.gov/27664581High spatial correlation in brain connectivity between micturition and resting states within bladder-related networks using 7 T MRI in multiple sclerosis women with voiding dysfunction.
Zhaoyue Shi, Khue Tran, Christof Karmonik...
https://pubmed.ncbi.nlm.nih.gov/33512570Are White Matter Tract Integrities Different in Multiple Sclerosis Women With Voiding Dysfunction?
Khue Tran, Christof Karmonik, Timothy B Boone...
https://pubmed.ncbi.nlm.nih.gov/32265400Therapeutic effects of non-invasive, individualized, transcranial neuromodulation treatment for voiding dysfunction in multiple sclerosis patients: study protocol for a pilot clinical trial.
Khue Tran, Zhaoyue Shi, Christof Karmonik...
https://pubmed.ncbi.nlm.nih.gov/33757581Evaluating noninvasive brain stimulation to treat overactive bladder in individuals with multiple sclerosis: a randomized controlled trial protocol.
Betsy H Salazar, Kristopher A Hoffman, John A Lincoln...
https://pubmed.ncbi.nlm.nih.gov/38273296