Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome (IcBrainStim)
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|ClinicalTrials.gov Identifier: NCT04734847|
Recruitment Status : Recruiting
First Posted : February 2, 2021
Last Update Posted : June 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Interstitial Cystitis Bladder Pain Syndrome||Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Device: Sham Repetitive Transcranial Magnetic Stimulation (Sham-rTMS)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome: Reducing Pain by Improving Brain and Muscle Activity|
|Actual Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2025|
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).
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Non-invasive magnetic stimulation of the brain
Sham Comparator: Sham rTMS
Identical to the High-frequency rTMS arm except delivered with an inert "sham" stimulation coil.
Device: Sham Repetitive Transcranial Magnetic Stimulation (Sham-rTMS)
Device that appears identical to the active rTMS device, but does not produce any magnetic field and does not stimulate the brain.
- Longer-term Pain [ Time Frame: Before first treatment to 3 weeks after last treatment ]Change in Visual Analog Scale of Pain. This scale ranges from 0 (no pain) to 10 (worst pain imaginable), so higher scores indicate more pain.
- Shorter-term Pain [ Time Frame: Before first treatment to 1 day later just before second treatment ]Change in Visual Analog Scale of Pain. This scale ranges from 0 (no pain) to 10 (worst pain imaginable), so higher scores indicate more pain.
- Global Response Assessment [ Time Frame: 3 weeks after last treatment ]Global Response Assessment (GRA)
- fALFF in Pelvic-SMA [ Time Frame: One hour before and one hour after first treatment ]Change in fractional amplitude of low-frequency fluctuations (fALFF) derived from functional magnetic resonance imaging (fMRI) in targeted region of the brain (pelvic-SMA)
- Pelvic floor muscle activity [ Time Frame: Just before to between five and ten minutes after start of first treatment ]Change in activity of pelvic floor muscles as measured by electromyography (EMG). EMG is a physiological parameter measuring the electrical potential generated by a muscle, indicative of its activity. EMG is measured in micro-volts and then converted to percent change.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04734847
|Contact: Jason J Kutch, PhDfirstname.lastname@example.org|
|Contact: Larissa V Rodriguez, MDemail@example.com|
|United States, California|
|University of Southern California||Recruiting|
|Los Angeles, California, United States, 90049|
|Contact: Jason J Kutch, PhD 323-442-2932 firstname.lastname@example.org|
|Principal Investigator:||Jason J Kutch, PhD||University of Southern California|