rTMS for Interstitial Cystitis

(IcBrainStim Trial)

Overseen By Larissa V Rodriguez, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Neurological conditions, Auto-immune disorders, Cancer, Psychiatric disorders, Severe cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 week

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help women with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), a condition causing chronic bladder pain. Researchers are using repetitive transcranial magnetic stimulation (rTMS), which sends magnetic pulses to specific brain areas to determine if it reduces pain. The study includes two groups: one receives the real magnetic treatment, while the other receives a placebo version for comparison. Women with IC/BPS who have experienced urologic symptoms most of the time in the last three months may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for IC/BPS.

Do I need to stop my current medications for the rTMS trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that rTMS is safe for treating Interstitial Cystitis?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe with few side effects. Many studies have found that patients tolerate rTMS well. It has been used in various treatments, such as for chronic pain, with few reports of serious problems.

Responses may vary, but common side effects are usually mild, including headaches or slight discomfort at the treatment site. These effects often resolve shortly after the session.

Overall, rTMS has been safely used in many studies, suggesting it could be a promising option for managing conditions like interstitial cystitis and bladder pain syndrome. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Repetitive Transcranial Magnetic Stimulation (rTMS) for interstitial cystitis is unique because it offers a non-invasive approach that targets brain regions controlling pelvic floor muscles, potentially addressing pain and urinary symptoms directly from a neurological angle. Unlike standard treatments like oral medications or bladder instillations, which mainly focus on symptom management, rTMS uses magnetic fields to stimulate specific areas of the brain, possibly reducing symptoms more effectively. Researchers are excited because rTMS has the potential to offer faster relief, with noticeable results after just five consecutive daily sessions, presenting a promising alternative for those seeking quicker and non-invasive options.

What evidence suggests that rTMS might be an effective treatment for Interstitial Cystitis?

Research has shown that repetitive transcranial magnetic stimulation (rTMS), one of the treatments studied in this trial, can help reduce pain in people with interstitial cystitis/bladder pain syndrome (IC/BPS). In one study, participants experienced complete relief from bladder pain, and their need to urinate frequently decreased by 60–80%. Another study found that targeting brain areas controlling muscle activity can lower pain levels in IC/BPS patients. These findings suggest that rTMS could effectively manage pain and improve the quality of life for those with IC/BPS. Participants in this trial may receive either high-frequency rTMS or sham rTMS as part of the study. ^{1 6 7 8 9}

Who Is on the Research Team?

Jason J Kutch, PhD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for women over 18 with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) who've had urologic symptoms most of the time in the last 3 months. They must not have cancer, severe organ disease, major psychiatric disorders, ongoing neurological conditions affecting bladder or bowel, or be pregnant.

Inclusion Criteria

I am female.

I have been diagnosed with interstitial cystitis/bladder pain syndrome for the last 3 months.

You do not have severe pelvic pain.

Exclusion Criteria

I have symptoms from a narrowed urethra.

I do not have conditions like seizures, chronic headaches, or pregnancy that prevent MRI or rTMS use.

You have severe mental health conditions right now.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high-frequency or sham rTMS treatment for 5 consecutive days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for changes in pain and brain/muscle activity

3 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation (rTMS)
• Sham Repetitive Transcranial Magnetic Stimulation (Sham-rTMS)

Trial Overview

The study tests if non-invasive brain stimulation (rTMS) can reduce IC/BPS pain by targeting brain areas that control pelvic muscles. A sham procedure (Sham-rTMS), which mimics rTMS without active treatment, is used for comparison.

How Is the Trial Designed?

Group I: High-frequency rTMS Active Control 1 Intervention

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).

Group II: Sham rTMS Placebo Group 1 Intervention

Identical to the High-frequency rTMS arm except delivered with an inert "sham" stimulation coil.

Repetitive Transcranial Magnetic Stimulation (rTMS) is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as rTMS for:

• Depression
• Smoking cessation

Approved in European Union as rTMS for:

• Depression

Approved in Canada as rTMS for:

• Depression

Approved in Japan as rTMS for:

• Depression

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Published Research Related to This Trial

A 68-year-old woman with bladder pain syndrome experienced complete relief from suprapubic pain and a 60-80% reduction in micturition frequency after 16 sessions of high-intensity, low-frequency rTMS targeting the dorsolateral prefrontal cortex.

This study is the first to demonstrate that rTMS can effectively alleviate symptoms of bladder pain syndrome, improving not only pain and urinary symptoms but also overall quality of life and daily functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Relief of Painful Bladder Syndrome by High-Intensity, Low-Frequency Repetitive Transcranial Magnetic Stimulation of the Right and Left Dorsolateral Prefrontal Cortices. Nizard, J., Esnault, J., Bouche, B., et al.[2020]

In a study of 86 females with interstitial cystitis, a combination of intravesical electrostimulation and electromagnetophoresis with heparin significantly reduced pain, with 60% of participants reporting pain as 'rare'.

The treatment also halved the urgency to urinate and increased the mean effective bladder volume by 46.2%, indicating a substantial improvement in bladder function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Complex local and central therapy of interstitial cystitis with devices AMUS-01-INTRAMAG and AMO-ATOS-E]. Rokhlokov, IM., Raĭgorodskiĭ, IuM., Timoshenko, VO., et al.[2012]

In a study involving multiple sclerosis (MS) patients with lower urinary tract symptoms, 5-Hz repetitive transcranial magnetic stimulation (rTMS) applied over the motor cortex for five consecutive days improved the voiding phase of urination.

The results suggest that increasing excitability in the corticospinal tract may help improve bladder function by enhancing detrusor contraction and urethral sphincter relaxation in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of motor cortex rTMS on lower urinary tract dysfunction in multiple sclerosis. Centonze, D., Petta, F., Versace, V., et al.[2022]

In a study of 21 patients with chronic pelvic pain from interstitial cystitis, sacral neuromodulation (InterStim) significantly reduced pain levels and narcotic use, with a 36% decrease in mean morphine dose equivalents after implantation.

The majority of patients (20 out of 21) reported moderate to marked improvement in pain, and four patients were able to stop using narcotics altogether after the treatment, indicating the efficacy of this intervention for those with refractory symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacral neuromodulation decreases narcotic requirements in refractory interstitial cystitis. Peters, KM., Konstandt, D.[2022]

In a study involving 15 patients with Bladder Pain Syndrome/Interstitial Cystitis, repetitive Transcranial Magnetic Stimulation (rTMS) significantly reduced chronic pelvic pain and improved urinary symptoms compared to sham treatment.

rTMS was found to enhance quality of life without any serious adverse events, indicating it is a safe and effective adjunct therapy for patients whose pain does not respond to standard drug treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation for chronic neuropathic pain in patients with bladder pain syndrome/interstitial cystitis. Cervigni, M., Onesti, E., Ceccanti, M., et al.[2019]

In a study of 25 patients with refractory interstitial cystitis, sacral neuromodulation significantly improved symptoms, with 17 patients qualifying for permanent implantation after showing at least 50% improvement in key measures.

At an average follow-up of 14 months, patients experienced substantial reductions in daytime frequency (from 17.1 to 8.7), nocturia (from 4.5 to 1.1), and average pain (from 5.8 to 1.6), indicating that sacral neuromodulation is both safe and effective for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacral neuromodulation for the symptomatic treatment of refractory interstitial cystitis: a prospective study. Comiter, CV.[2019]

In a study of 34 female patients with interstitial cystitis, sacral neuromodulation significantly reduced pelvic pain and urgency/frequency symptoms over a mean follow-up of 86 months, indicating its long-term efficacy.

The treatment showed a substantial decrease in pain scores from an average of 6.5 to 2.4 on the visual analog pain scale, demonstrating that sacral neuromodulation can be a successful option for patients who have not responded to standard drug therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimum 6-year outcomes for interstitial cystitis treated with sacral neuromodulation. Marinkovic, SP., Gillen, LM., Marinkovic, CM.[2022]

Long-term transcutaneous electrical stimulation treatment can effectively help bring interstitial cystitis into remission, offering a conservative management option for patients.

The treatment appears to be more effective for the classic subtype of interstitial cystitis compared to the nonulcer subtype, suggesting that different subtypes may respond differently to this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation in classic and nonulcer interstitial cystitis. Fall, M., Lindström, S.[2006]

This study aims to evaluate the effects of transcranial direct current stimulation (tDCS) on pain, functionality, and mood in women with interstitial cystitis, using a randomized controlled trial design with two groups: active and sham stimulation.

If effective, tDCS could provide a safe, low-cost, and easy-to-use complementary treatment for interstitial cystitis, potentially leading to decreased pain and improved quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current electrical stimulation for the treatment of interstitial cystitis: A study protocol. Dutra, LRDV., Silva-Filho, E., Oliveira, MC., et al.[2021]

Repetitive transcranial magnetic stimulation (rTMS) was found to be well tolerated in 11 patients with treatment-resistant chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), with no serious side effects reported and only mild headaches in a few cases.

The treatment showed moderate efficacy, with significant reductions in pain scores observed immediately after treatment and at follow-ups, suggesting rTMS could be a promising option for patients who do not respond to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Pilot Study. Nikkola, J., Holm, A., Seppänen, M., et al.[2020]

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