Interstitial CystitisIcBrainStimNCT04734847
Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Interstitial Cystitis and Bladder Pain Syndrome, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Interstitial Cystitis, Bladder Pain Syndrome
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90049
About this study
Official title: Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome: Reducing Pain by Improving Brain and Muscle Activity
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.
Read the detailed description
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a common, chronic, and debilitating condition in women. The underlying cause of IC/BPS remains unknown. We recently published the first functional magnetic resonance imaging (fMRI) study comparing brain function in women with IC/BPS to healthy women. We found that women with IC/BPS have altered resting activity in supplementary motor area (SMA). Specifically, these changes appear in a part of SMA that we have shown to control pelvic floor muscle activity. We call this part of SMA "pelvic-SMA". Our results provide the first potential explanation for extensive published reports of increased pelvic floor muscle activity in women with IC/BPS. We hypothesize that we are observing evidence of an important theory of chronic pain: motor cortical changes occur that are initially beneficial to increase protective muscle activity but are ultimately maladaptive and perpetuate pain. If this theory is true, it should be possible to reduce pain and muscle activity by improving brain activity. The proposed work is to do exactly that. Using non-invasive repetitive transcranial magnetic stimulation (rTMS) directed at pelvic-SMA, we aim to determine if we can reduce pain (Aim 1), improve resting brain activity (fMRI) and resting pelvic floor muscle electromyographic (EMG) activity in IC/BPS (Aim 2), and to link the pain reductions to fMRI/EMG improvements to develop a causal mediation model of IC/BPS symptoms (Aim 3). We will recruit 50 women with IC/BPS to participate in the study, and participants will be randomized to 2 groups of 25: high-frequency (active) or sham (inert). Our preliminary data suggest that high-frequency stimulation is the best stimulation protocol for reducing pain and improving pelvic-SMA activity and resting pelvic floor muscle activity. Our preliminary results agree with a large body of literature suggesting that high-frequency rTMS applied to motor cortex is the best stimulus paradigm to reduce pain, but our proposed work has the potential to greatly innovate the field of non-invasive brain stimulation for pain by providing a mechanism by which the stimulation can improve deficiencies in motor function in chronic pain patients.
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Sham Repetitive Transcranial Magnetic Stimulation (Sham-rTMS)
- Keywords
- Chronic Pain, Transcranial Magnetic Stimulation
- Medical subject headings
- Cystitis, Interstitial, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Non-invasive magnetic stimulation of the brain
Sham Repetitive Transcranial Magnetic Stimulation (Sham-rTMS)Device
Device that appears identical to the active rTMS device, but does not produce any magnetic field and does not stimulate the brain.
| Study group | Role | What they receive |
|---|---|---|
| High-frequency rTMS | Active comparator | 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). Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Sham rTMS | Sham comparator | Identical to the High-frequency rTMS arm except delivered with an inert "sham" stimulation coil. Receives: Device: Sham Repetitive Transcranial Magnetic Stimulation (Sham-rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before first treatment to 1 day later just before second treatment
Global Response Assessment
Global Response Assessment (GRA)
Measured: 3 weeks after last treatment
Secondary outcomes (2)
fALFF in Pelvic-SMA
Change in fractional amplitude of low-frequency fluctuations (fALFF) derived from functional magnetic resonance imaging (fMRI) in targeted region of the brain (pelvic-SMA)
Measured: One hour before and one hour after first treatment
Pelvic floor muscle activity
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.
Measured: Just before to between five and ten minutes after start of first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Jun 2021
- Primary completion20 May 2026
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Kutch, University of Southern California
- Investigators
- Jason J Kutch, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734847
- Sponsor's protocol ID
- APP-20-05139
- Acronym
- IcBrainStim
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2021
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39261949
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome: Reducing Pain by Improving Brain and Muscle Activity
- ClinicalTrials.gov ID
- NCT04734847
- Acronym / sponsor ID
- IcBrainStim / APP-20-05139
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Keywords
- Chronic Pain, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a common, chronic, and debilitating condition in women. The underlying cause of IC/BPS remains unknown. We recently published the first functional magnetic resonance imaging (fMRI) study comparing brain function in women with IC/BPS to healthy women. We found that women with IC/BPS have altered resting activity in supplementary motor area (SMA). Specifically, these changes appear in a part of SMA that we have shown to control pelvic floor muscle activity. We call this part of SMA "pelvic-SMA". Our results provide the first potential explanation for extensive published reports of increased pelvic floor muscle activity in women with IC/BPS. We hypothesize that we are observing evidence of an important theory of chronic pain: motor cortical changes occur that are initially beneficial to increase protective muscle activity but are ultimately maladaptive and perpetuate pain. If this theory is true, it should be possible to reduce pain and muscle activity by improving brain activity. The proposed work is to do exactly that. Using non-invasive repetitive transcranial magnetic stimulation (rTMS) directed at pelvic-SMA, we aim to determine if we can reduce pain (Aim 1), improve resting brain activity (fMRI) and resting pelvic floor muscle electromyographic (EMG) activity in IC/BPS (Aim 2), and to link the pain reductions to fMRI/EMG improvements to develop a causal mediation model of IC/BPS symptoms (Aim 3). We will recruit 50 women with IC/BPS to participate in the study, and participants will be randomized to 2 groups of 25: high-frequency (active) or sham (inert). Our preliminary data suggest that high-frequency stimulation is the best stimulation protocol for reducing pain and improving pelvic-SMA activity and resting pelvic floor muscle activity. Our preliminary results agree with a large body of literature suggesting that high-frequency rTMS applied to motor cortex is the best stimulus paradigm to reduce pain, but our proposed work has the potential to greatly innovate the field of non-invasive brain stimulation for pain by providing a mechanism by which the stimulation can improve deficiencies in motor function in chronic pain patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-frequency rTMS | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation (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 rTMS | Sham comparator | Device: Sham Repetitive Transcranial Magnetic Stimulation (Sham-rTMS)Identical to the High-frequency rTMS arm except delivered with an inert "sham" stimulation coil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)Non-invasive magnetic stimulation of the brain | Device | High-frequency rTMS |
| 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. | Device | Sham rTMS |
Primary outcome
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)
2 secondary outcomes
fALFF in Pelvic-SMA
Time frame: One hour before and one hour after first treatment
Pelvic floor muscle activity
Time frame: Just before to between five and ten minutes after start of first treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Derived from this study: PubMed 39261949Johnson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason J Kutch, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Interstitial Cystitis and Bladder Pain Syndrome, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longer-term Pain (time frame: Before first treatment to 3 weeks after last treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04734847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.