Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome
IcBrainStim
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2021
CompletedFirst Posted
Study publicly available on registry
February 2, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2025
CompletedMay 23, 2024
May 1, 2024
3.6 years
January 27, 2021
May 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Longer-term Pain
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.
Before first treatment to 3 weeks after last treatment
Shorter-term Pain
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.
Before first treatment to 1 day later just before second treatment
Global Response Assessment
Global Response Assessment (GRA)
3 weeks after last treatment
Secondary Outcomes (2)
fALFF in Pelvic-SMA
One hour before and one hour after first treatment
Pelvic floor muscle activity
Just before to between five and ten minutes after start of first treatment
Study Arms (2)
High-frequency rTMS
ACTIVE COMPARATORIntensity: 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 rTMS
SHAM COMPARATORIdentical to the High-frequency rTMS arm except delivered with an inert "sham" stimulation coil.
Interventions
Non-invasive magnetic stimulation of the brain
Device that appears identical to the active rTMS device, but does not produce any magnetic field and does not stimulate the brain.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Southern California
Los Angeles, California, 90049, United States
Related Publications (1)
Johnson EV, Bachmann M, Yani MS, Eckel SP, Garcia GI, Rodriguez LV, Kutch JJ. Reducing pain by improving brain and muscle activity with motor cortical neuromodulation in women with interstitial cystitis/bladder pain syndrome: a study protocol for a randomized controlled trial. Trials. 2024 Sep 12;25(1):609. doi: 10.1186/s13063-024-08450-w.
PMID: 39261949DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason J Kutch, PhD
University of Southern California
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 27, 2021
First Posted
February 2, 2021
Study Start
June 1, 2021
Primary Completion
January 1, 2025
Study Completion
August 15, 2025
Last Updated
May 23, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share