Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome: Reducing Pain by Improving Brain and Muscle Activity

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a common, chronic, and debilitating condition in women. Preliminary evidence suggests that IC/BPS pain can be reduced applying non-invasive repetitive transcranial magnetic stimulation (rTMS) to areas of the brain that regulate pelvic floor muscle activity. However, prior studies have examined rTMS in a very limited sample and have not examined changes in brain or pelvic floor muscle activity to determine the mechanism of rTMS for IC/BPS. This study is designed to directly address these limitations.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of Southern California
RECRUITING
Los Angeles
Contact Information
Primary
Jason J Kutch, PhD
kutch@pt.usc.edu
323-442-2932
Backup
Larissa V Rodriguez, MD
lrodriguez@med.usc.edu
310-601-3366
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2025-08-15
Participants
Target number of participants: 50
Treatments
Active_comparator: High-frequency 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).
Sham_comparator: Sham rTMS
Identical to the High-frequency rTMS arm except delivered with an inert sham stimulation coil.
Related Therapeutic Areas
Sponsors
Leads: University of Southern California

This content was sourced from clinicaltrials.gov

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