rTMS for Interstitial Cystitis
(IcBrainStim Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Southern California
Disqualifiers: Neurological conditions, Auto-immune disorders, Cancer, Psychiatric disorders, Severe cardiac disease, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
16789How 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.
126710Eligibility Criteria
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 18 years old or older.
I am female.
I have been diagnosed with interstitial cystitis/bladder pain syndrome for the last 3 months.
+1 more
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.
+5 more
Trial Timeline
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)
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Southern CaliforniaLos Angeles, CA
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Who Is Running the Clinical Trial?
University of Southern CaliforniaLead Sponsor
References
Repetitive transcranial magnetic stimulation for chronic neuropathic pain in patients with bladder pain syndrome/interstitial cystitis. [2019]To evaluate the efficacy, safety, and tolerability of repetitive Transcranial Magnetic Stimulation (rTMS) associated with standard drug therapies for neuropathic pain that does not respond to pharmacological treatment alone in patients with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC). Secondary goals were to assess the effects of rTMS on Lower Urinary Tract Symptoms (LUTS) and Quality of Life (QOL).
Sacral neuromodulation for the symptomatic treatment of refractory interstitial cystitis: a prospective study. [2019]The efficacy of sacral neuromodulation for the treatment of symptoms in patients with refractory interstitial cystitis was evaluated.
[Complex local and central therapy of interstitial cystitis with devices AMUS-01-INTRAMAG and AMO-ATOS-E]. [2012]A total of 86 females with interstitial cystitis (IC) aged 26-52 years with the disease history over 2.7 years were exposed to intravesical electrostimulation in combination with electromagnetophoresis of heparin-containing mixture of medicines. Relief of pain syndrome and elimination of central hypersensitization were achieved with local procedures on the urinary bladder (UB) alternating (every other day) with procedures of transcranial electrostimulation (TES-therapy, mesodiencephalic modulation). The above treatment proved effective: subjective assessment of pain lowered to "rare" in 60% females, urgency decreased 2-fold, mean effective volume of the bladder increased by 46.2%.
Transcutaneous electrical nerve stimulation in classic and nonulcer interstitial cystitis. [2006]Long-term treatment of interstitial cystitis by transcutaneous electrical stimulation provides a conservative means of bringing the disease to remission. The overall results are better in the classic than in the nonulcer subtype of interstitial cystitis. These findings are considered in relation to the role of neutral factors in the disease.
Repetitive Transcranial Magnetic Stimulation for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Pilot Study. [2020]To evaluate the feasibility, efficacy, and safety of repetitive transcranial magnetic stimulation (rTMS) in patients with treatment-resistant chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).
Transcranial direct current electrical stimulation for the treatment of interstitial cystitis: A study protocol. [2021]Interstitial cystitis or painful bladder syndrome is a chronic disorder that presents an unknown etiology, with no generally accepted treatment. Although there is no gold standard treatment, transcranial direct current stimulation (tDCS) has shown efficacy in several chronic pain syndromes with decrease in pain, and improved functionality and mood. tDCS could be a safe, ease to use, and low-cost complementary intervention for patients with interstitial cystitis.
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]Aim: To show the value of low-frequency repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (DLPFC) to treat bladder pain syndrome (BPS), characterized by suprapubic pain, urgency and increased micturition frequency. Methods: A 68-year-old woman with BPS underwent 16 sessions of high-intensity, low-frequency (1 Hz) rTMS of the DLPFC, first on the right hemisphere (one daily session for 5 days, followed by one weekly session for 5 weeks), and then on the left hemisphere (one monthly session for 6 months). Results: At the end of the rTMS protocol, suprapubic pain completely vanished, micturition frequency dramatically decreased (by 60-80%), while fatigue and sleep quality improved (by 57-60%). The patient reported an overall satisfaction rate of 80% and her activities of daily living tending to normalize. Conclusion: This is the first report showing that high-intensity, low-frequency rTMS delivered on the DLPFC region of both hemispheres can relieve most symptoms of BPS (pain, urinary symptoms, and interference with physical functioning) in clinical practice.
Effects of motor cortex rTMS on lower urinary tract dysfunction in multiple sclerosis. [2022]We tested the effects of 5-Hz rTMS over the motor cortex in multiple sclerosis (MS) subjects complaining of lower urinary tract symptoms either in the filling or voiding phase. Our data show that motor cortex stimulation for five consecutive days over two weeks ameliorates the voiding phase of the micturition cycle, suggesting that enhancing corticospinal tract excitability might be useful to ameliorate detrusor contraction and/or urethral sphincter relaxation in MS patients with bladder dysfunction.
Sacral neuromodulation decreases narcotic requirements in refractory interstitial cystitis. [2022]To assess the efficacy of long-term sacral neuromodulation (InterStim(R), Medtronic Inc., Minneapolis, MN) in treating chronic pelvic pain associated with interstitial cystitis (IC, a symptom complex of urinary urgency, frequency and pelvic pain, often necessitating narcotics) refractory to standard therapy.
Minimum 6-year outcomes for interstitial cystitis treated with sacral neuromodulation. [2022]Interstitial cystitis is a multifaceted medical condition consisting of pelvic pain, urgency, and frequency. Can sacral neuromodulation be successfully utilized for the medium term of ≥ 6 years in interstitial cystitis patients for whom standard drug therapies have failed?