50 Participants Needed

rTMS for Interstitial Cystitis

(IcBrainStim Trial)

JJ
LV
Overseen ByLarissa V Rodriguez, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses magnetic pulses to stimulate the brain in women with chronic bladder pain. The goal is to reduce pain and muscle issues by improving brain function. The study will involve 50 women. Pulsed electromagnetic field (PEMF) therapy has been studied for its potential to reduce pain and improve quality of life in various conditions, including chronic pain syndromes.

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.

Is rTMS generally safe for humans?

Research indicates that repetitive Transcranial Magnetic Stimulation (rTMS) is generally safe for humans, as studies have evaluated its safety and tolerability in treating conditions like chronic neuropathic pain and bladder pain syndrome.12345

How does rTMS treatment differ from other treatments for interstitial cystitis?

Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it uses magnetic fields to stimulate specific areas of the brain, which can help reduce pain and improve symptoms in interstitial cystitis. Unlike standard drug therapies, rTMS is non-invasive and targets the brain's dorsolateral prefrontal cortex to alleviate pain and improve quality of life.12367

What data supports the effectiveness of the treatment Repetitive Transcranial Magnetic Stimulation (rTMS) for Interstitial Cystitis?

Research shows that rTMS, when used with standard drug therapies, can help reduce chronic pain in patients with Bladder Pain Syndrome/Interstitial Cystitis who do not respond to medication alone. It also suggests improvements in urinary symptoms and quality of life.168910

Who Is on the Research Team?

JJ

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.
See 5 more

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?
2Treatment groups
Active Control
Placebo Group
Group I: High-frequency rTMSActive Control1 Intervention
Group II: Sham rTMSPlacebo Group1 Intervention

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

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Approved in United States as rTMS for:
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Approved in European Union as rTMS for:
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Approved in Canada as rTMS for:
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Approved in Japan as rTMS for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials
956
Recruited
1,609,000+

Published Research Related to This Trial

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.
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.
Sacral neuromodulation for the symptomatic treatment of refractory interstitial cystitis: a prospective study.Comiter, CV.[2019]
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.
[Complex local and central therapy of interstitial cystitis with devices AMUS-01-INTRAMAG and AMO-ATOS-E].Rokhlokov, IM., RaΔ­gorodskiΔ­, IuM., Timoshenko, VO., et al.[2012]

Citations

Repetitive transcranial magnetic stimulation for chronic neuropathic pain in patients with bladder pain syndrome/interstitial cystitis. [2019]
Sacral neuromodulation for the symptomatic treatment of refractory interstitial cystitis: a prospective study. [2019]
3.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Complex local and central therapy of interstitial cystitis with devices AMUS-01-INTRAMAG and AMO-ATOS-E]. [2012]
Transcutaneous electrical nerve stimulation in classic and nonulcer interstitial cystitis. [2006]
Repetitive Transcranial Magnetic Stimulation for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Pilot Study. [2020]
Transcranial direct current electrical stimulation for the treatment of interstitial cystitis: A study protocol. [2021]
Long-Term Relief of Painful Bladder Syndrome by High-Intensity, Low-Frequency Repetitive Transcranial Magnetic Stimulation of the Right and Left Dorsolateral Prefrontal Cortices. [2020]
Effects of motor cortex rTMS on lower urinary tract dysfunction in multiple sclerosis. [2022]
Sacral neuromodulation decreases narcotic requirements in refractory interstitial cystitis. [2022]
Minimum 6-year outcomes for interstitial cystitis treated with sacral neuromodulation. [2022]
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