Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome (IcBrainStim)
Interstitial Cystitis, Bladder Pain Syndrome
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring Chronic Pain, Transcranial Magnetic Stimulation
Eligibility Criteria
Inclusion Criteria:
- Be at least 18 years old.
- Be female.
- Have a diagnosis of IC/BPS by the referring physician, with urologic symptoms present a majority of the time during the most recent 3 months
- Screen within standard limits for pelvic pain
Exclusion Criteria:
- Symptomatic urethral stricture
- On-going neurological conditions affecting the bladder or bowel
- Active auto-immune or infectious disorders
- History of cystitis caused by tuberculosis or radiation or chemotherapies
- History of non-dermatologic cancer
- Current major psychiatric disorders
- Severe cardiac, pulmonary, renal, or hepatic disease
- Conditions or the use of medical devices that are contraindications for either fMRI or rTMS procedures, including pregnancy, seizure disorders, or chronic headaches
Sites / Locations
- University of Southern CaliforniaRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
High-frequency rTMS
Sham rTMS
Intensity: rTMS treatment intensity determined using resting motor threshold (RMT). Treatment will be delivered at 80% of the RMT. Site of Stimulation: Region of supplementary motor area (SMA) that regulates pelvic floor muscle activity. This target is defined in Montreal Neurological Institute (MNI) Coordinates of X=-2, Y=-16, and Z=68 mm. Frequency: 10 Hz. Duration: 20 Trains, 10 second duration, 50 second inter-train interval. Total number of pulses per session: 2000. Total number of session: 5 (one session per day for 5 consecutive days).
Identical to the High-frequency rTMS arm except delivered with an inert "sham" stimulation coil.