RECRUITING

Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a common, chronic, and debilitating condition in women. Preliminary evidence suggests that IC/BPS pain can be reduced applying non-invasive repetitive transcranial magnetic stimulation (rTMS) to areas of the brain that regulate pelvic floor muscle activity. However, prior studies have examined rTMS in a very limited sample and have not examined changes in brain or pelvic floor muscle activity to determine the mechanism of rTMS for IC/BPS. This study is designed to directly address these limitations.

Official Title

Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome: Reducing Pain by Improving Brain and Muscle Activity

Quick Facts

Study Start:2021-06-01
Study Completion:2025-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04734847

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Be at least 18 years old.
  2. 2. Be female.
  3. 3. Have a diagnosis of IC/BPS by the referring physician, with urologic symptoms present a majority of the time during the most recent 3 months
  4. 4. Screen within standard limits for pelvic pain
  1. 1. Symptomatic urethral stricture
  2. 2. On-going neurological conditions affecting the bladder or bowel
  3. 3. Active auto-immune or infectious disorders
  4. 4. History of cystitis caused by tuberculosis or radiation or chemotherapies
  5. 5. History of non-dermatologic cancer
  6. 6. Current major psychiatric disorders
  7. 7. Severe cardiac, pulmonary, renal, or hepatic disease
  8. 8. Conditions or the use of medical devices that are contraindications for either fMRI or rTMS procedures, including pregnancy, seizure disorders, or chronic headaches

Contacts and Locations

Study Contact

Jason J Kutch, PhD
CONTACT
323-442-2932
kutch@pt.usc.edu
Larissa V Rodriguez, MD
CONTACT
310-601-3366
lrodriguez@med.usc.edu

Principal Investigator

Jason J Kutch, PhD
PRINCIPAL_INVESTIGATOR
University of Southern California

Study Locations (Sites)

University of Southern California
Los Angeles, California, 90049
United States

Collaborators and Investigators

Sponsor: University of Southern California

  • Jason J Kutch, PhD, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-01
Study Completion Date2025-08-15

Study Record Updates

Study Start Date2021-06-01
Study Completion Date2025-08-15

Terms related to this study

Keywords Provided by Researchers

  • Chronic Pain
  • Transcranial Magnetic Stimulation

Additional Relevant MeSH Terms

  • Interstitial Cystitis
  • Bladder Pain Syndrome