Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2024-01-08
2026-07-31
Brief Summary
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Non-invasive neuromodulation with repetitive transcranial magnetic stimulation (rTMS) can be used in research settings to investigate responses to focal regional brain activation. In the clinical setting, rTMS normalizes brain activity with associated clinical benefits in conditions such as refractory depression. rTMS has been studied for effects on lower urinary tract symptoms (LUTS) in bladder pain and neurogenic lower urinary tract symptoms (LUTS) populations.
Unlike many standard of care OAB interventions, the safety of rTMS is well-reported, including for use in elderly populations and those with cognitive impairment. Functional magnetic resonance imaging (fMRI) to evaluate neuroplasticity is emerging as an essential tool to define OAB phenotypes; however, phenotyping studies guided by mechanistic data are lacking. The effects of central neuromodulation on regions involved OAB mechanisms and associated physiological and clinical responses are unknown. This study will be the first to report neuroplasticity, physiologic, and clinical effects of central neuromodulation with rTMS in adults with OAB.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Transcranial magnetic stimulation
All study subjects undergo five sessions of rTMS. The 40-minute sessions target the supplemental motor area (inhibitory stimulation) and prefrontal cortex (excitatory stimulation)
Transcranial Magnetic Stimulation
Magstim Rapid2 Therapy System
Interventions
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Transcranial Magnetic Stimulation
Magstim Rapid2 Therapy System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 40 to 80 years old
* 3 months of OAB symptoms without active urinary tract infection currently
* Bladder diary:
* Mean voids/24 hours ≥ 8.0
* Mean urgency episodes/24 hours ≥ 3.0
* Montreal Cognitive Assessment (MoCA) score \>10
Exclusion Criteria
* Contraindication to MRI or to the Rapid2 Magstim Device as listed in the operator manual
* Qmax \< 10 ml/s in males on uroflow
* \< 20th percentile on Liverpool nomogram
* Postvoid residual volume ≥ 200 mL, suprapubic or indwelling catheter
* Personal or immediate family history of seizure disorder
* Taking (bupropion) Wellbutrin or heavy alcohol use
* Parkinson's disease, Multiple sclerosis, spinal cord injury
* Intracranial lesions and hemorrhagic stroke within the last 12 months
* History of interstitial cystitis, pelvic radiation, bladder augmentation
* Intradetrusor botulinum toxin injections within 6 months
* Pelvic floor therapy within 2 months.
* Active/on-mode Sacral nerve stimulator (eligible if turned off)
* Incarcerated patients
40 Years
80 Years
ALL
No
Sponsors
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The Methodist Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Michelle Almarez, BBA
Role: STUDY_DIRECTOR
Houston Methodist Obstetrics & Gynecology Department
Locations
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Houston Methodist Hospital
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PRO00037607
Identifier Type: -
Identifier Source: org_study_id
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