What side effects are associated with this type of intervention?

Common treatments for Interstitial Cystitis (IC) include analgesics, which can cause gastrointestinal issues and dependency if narcotics are used; pelvic floor muscle therapy, which may result in temporary discomfort; intravesical instillation of lidocaine, which can cause local irritation; sacral neuromodulation, which has risks of device malfunction and infection; cyclosporine A, which can lead to nephrotoxicity, hypertension, and immunosuppression; and myofascial physical therapy, which may cause pain during treatment. While rTMS is not explicitly covered, it is generally considered safe with potential side effects like mild headaches and scalp discomfort.

What prior FDA approvals exist?

FDA-approved treatments for Interstitial Cystitis (IC) include oral medications like pentosan polysulfate sodium (Elmiron), which is the only oral drug specifically approved for IC. Other treatments include bladder instillations with dimethyl sulfoxide (DMSO) and various off-label medications such as amitriptyline and hydroxyzine. While rTMS is being studied for its potential to modulate brain activity to regulate pelvic floor muscle activity, it is not yet an FDA-approved treatment for IC. Current FDA-approved treatments do not specifically target brain modulation or pelvic floor muscle activity in the same manner as rTMS.

What other types of research exist?

Promising alternatives to rTMS for Interstitial Cystitis patients include sacral neuromodulation, which has shown symptomatic relief in observational studies, and botulinum toxin injections, which have demonstrated significant pain reduction in clinical trials. Cyclosporine A is another option, particularly for patients with Hunner lesions, though its use is limited by potential adverse effects.

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Neuromodulation

rTMS for Interstitial Cystitis (IcBrainStim Trial)

N/A

Recruiting

Led By Jason J Kutch, PhD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be at least 18 years old

Be female

Must not have

Symptomatic urethral stricture

Conditions or the use of medical devices that are contraindications for either fMRI or rTMS procedures, including pregnancy, seizure disorders, or chronic headaches

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one hour before and one hour after first treatment

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of rTMS include discomfort at the stimulation site, headache, lightheadedness, and a very low risk of seizure. The sham procedure may cause similar sensations but without actual stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have symptoms from a narrowed urethra.

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

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I have a neurological condition that affects my bladder or bowel.

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I have an active autoimmune or infectious condition.

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I have had cancer that was not skin cancer.

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I do not have severe heart, lung, kidney, or liver disease.

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I have had bladder inflammation due to tuberculosis, radiation, or chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one hour before and one hour after first treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one hour before and one hour after first treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and one hour before and one hour after first treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Global Response Assessment

Pain

Shorter-term Pain

Secondary study objectives

Pelvic floor muscle activity

fALFF in Pelvic-SMA

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: High-frequency rTMSActive Control1 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 rTMSPlacebo Group1 Intervention

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

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Interstitial Cystitis (IC) include oral medications like NSAIDs for pain relief, intravesical therapies such as lidocaine instillation to numb the bladder lining, and physical therapies like pelvic floor muscle therapy to alleviate muscle tenderness. These treatments aim to reduce pain, improve bladder function, and enhance quality of life. Repetitive Transcranial Magnetic Stimulation (rTMS) is an emerging therapy that modulates brain activity to regulate pelvic floor muscle activity, potentially reducing IC pain by altering neural pathways involved in pain perception and muscle control. This approach is significant for IC patients as it offers a non-invasive option that targets the neurological aspects of pain, providing relief where other treatments may have failed.

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