Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one hour before and one hour after first treatment
Awards & highlights
IcBrainStim Trial Summary
This trial will test whether transcranial magnetic stimulation (TMS) can help relieve pelvic pain in women with a chronic condition called IC/BPS. TMS involves using a magnetic coil to stimulate specific areas of the brain. This study will examine whether TMS can help by reducing pelvic floor muscle activity.
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.Check my eligibility
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.See study design
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.
IcBrainStim Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am female.
IcBrainStim Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Global Response Assessment
Pain
Shorter-term Pain
Secondary outcome measures
Pelvic floor muscle activity
fALFF in Pelvic-SMA
IcBrainStim 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.
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,238 Total Patients Enrolled
Jason J Kutch, PhDPrincipal InvestigatorUniversity of Southern California
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have a neurological condition that affects my bladder or bowel.I have an active autoimmune or infectious condition.I have had cancer that was not skin cancer.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.I do not have severe heart, lung, kidney, or liver disease.You do not have severe pelvic pain.I have had bladder inflammation due to tuberculosis, radiation, or chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: High-frequency rTMS
- Group 2: Sham rTMS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this experiment open to willing participants?
"The facts on clinicialtrials.gov affirm that this clinical trial is actively seeking participants, with its publication date beginning June 1st 2021 and the last update taking place October 18th 2022."
Answered by AI
What is the total number of participants currently registered in this research experiment?
"That is correct. According to information found on clinicaltrials.gov, the medical trial was posted during June 2021 and has been recently updated in October 2022. The study requires 50 individuals across one centre for enrollment."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger