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

Primary Purpose

Interstitial Cystitis, Bladder Pain Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham Repetitive Transcranial Magnetic Stimulation (Sham-rTMS)
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring Chronic Pain, Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be at least 18 years old.
  2. Be female.
  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. Screen within standard limits for pelvic pain

Exclusion Criteria:

  1. Symptomatic urethral stricture
  2. On-going neurological conditions affecting the bladder or bowel
  3. Active auto-immune or infectious disorders
  4. History of cystitis caused by tuberculosis or radiation or chemotherapies
  5. History of non-dermatologic cancer
  6. Current major psychiatric disorders
  7. Severe cardiac, pulmonary, renal, or hepatic disease
  8. Conditions or the use of medical devices that are contraindications for either fMRI or rTMS procedures, including pregnancy, seizure disorders, or chronic headaches

Sites / Locations

  • University of Southern CaliforniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

High-frequency rTMS

Sham rTMS

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Longer-term Pain
Change in Visual Analog Scale of Pain. This scale ranges from 0 (no pain) to 10 (worst pain imaginable), so higher scores indicate more pain.
Shorter-term Pain
Change in Visual Analog Scale of Pain. This scale ranges from 0 (no pain) to 10 (worst pain imaginable), so higher scores indicate more pain.
Global Response Assessment
Global Response Assessment (GRA)

Secondary Outcome Measures

fALFF in Pelvic-SMA
Change in fractional amplitude of low-frequency fluctuations (fALFF) derived from functional magnetic resonance imaging (fMRI) in targeted region of the brain (pelvic-SMA)
Pelvic floor muscle activity
Change in activity of pelvic floor muscles as measured by electromyography (EMG). EMG is a physiological parameter measuring the electrical potential generated by a muscle, indicative of its activity. EMG is measured in micro-volts and then converted to percent change.

Full Information

First Posted
January 27, 2021
Last Updated
March 11, 2023
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT04734847
Brief Title
Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome
Acronym
IcBrainStim
Official Title
Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome: Reducing Pain by Improving Brain and Muscle Activity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
August 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a common, chronic, and debilitating condition in women. The underlying cause of IC/BPS remains unknown. We recently published the first functional magnetic resonance imaging (fMRI) study comparing brain function in women with IC/BPS to healthy women. We found that women with IC/BPS have altered resting activity in supplementary motor area (SMA). Specifically, these changes appear in a part of SMA that we have shown to control pelvic floor muscle activity. We call this part of SMA "pelvic-SMA". Our results provide the first potential explanation for extensive published reports of increased pelvic floor muscle activity in women with IC/BPS. We hypothesize that we are observing evidence of an important theory of chronic pain: motor cortical changes occur that are initially beneficial to increase protective muscle activity but are ultimately maladaptive and perpetuate pain. If this theory is true, it should be possible to reduce pain and muscle activity by improving brain activity. The proposed work is to do exactly that. Using non-invasive repetitive transcranial magnetic stimulation (rTMS) directed at pelvic-SMA, we aim to determine if we can reduce pain (Aim 1), improve resting brain activity (fMRI) and resting pelvic floor muscle electromyographic (EMG) activity in IC/BPS (Aim 2), and to link the pain reductions to fMRI/EMG improvements to develop a causal mediation model of IC/BPS symptoms (Aim 3). We will recruit 50 women with IC/BPS to participate in the study, and participants will be randomized to 2 groups of 25: high-frequency (active) or sham (inert). Our preliminary data suggest that high-frequency stimulation is the best stimulation protocol for reducing pain and improving pelvic-SMA activity and resting pelvic floor muscle activity. Our preliminary results agree with a large body of literature suggesting that high-frequency rTMS applied to motor cortex is the best stimulus paradigm to reduce pain, but our proposed work has the potential to greatly innovate the field of non-invasive brain stimulation for pain by providing a mechanism by which the stimulation can improve deficiencies in motor function in chronic pain patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Bladder Pain Syndrome
Keywords
Chronic Pain, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-frequency rTMS
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Identical to the High-frequency rTMS arm except delivered with an inert "sham" stimulation coil.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
Non-invasive magnetic stimulation of the brain
Intervention Type
Device
Intervention Name(s)
Sham Repetitive Transcranial Magnetic Stimulation (Sham-rTMS)
Intervention Description
Device that appears identical to the active rTMS device, but does not produce any magnetic field and does not stimulate the brain.
Primary Outcome Measure Information:
Title
Longer-term Pain
Description
Change in Visual Analog Scale of Pain. This scale ranges from 0 (no pain) to 10 (worst pain imaginable), so higher scores indicate more pain.
Time Frame
Before first treatment to 3 weeks after last treatment
Title
Shorter-term Pain
Description
Change in Visual Analog Scale of Pain. This scale ranges from 0 (no pain) to 10 (worst pain imaginable), so higher scores indicate more pain.
Time Frame
Before first treatment to 1 day later just before second treatment
Title
Global Response Assessment
Description
Global Response Assessment (GRA)
Time Frame
3 weeks after last treatment
Secondary Outcome Measure Information:
Title
fALFF in Pelvic-SMA
Description
Change in fractional amplitude of low-frequency fluctuations (fALFF) derived from functional magnetic resonance imaging (fMRI) in targeted region of the brain (pelvic-SMA)
Time Frame
One hour before and one hour after first treatment
Title
Pelvic floor muscle activity
Description
Change in activity of pelvic floor muscles as measured by electromyography (EMG). EMG is a physiological parameter measuring the electrical potential generated by a muscle, indicative of its activity. EMG is measured in micro-volts and then converted to percent change.
Time Frame
Just before to between five and ten minutes after start of first treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be at least 18 years old. Be female. 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 Screen within standard limits for pelvic pain Exclusion Criteria: Symptomatic urethral stricture On-going neurological conditions affecting the bladder or bowel Active auto-immune or infectious disorders History of cystitis caused by tuberculosis or radiation or chemotherapies History of non-dermatologic cancer Current major psychiatric disorders Severe cardiac, pulmonary, renal, or hepatic disease Conditions or the use of medical devices that are contraindications for either fMRI or rTMS procedures, including pregnancy, seizure disorders, or chronic headaches
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason J Kutch, PhD
Phone
323-442-2932
Email
kutch@pt.usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Larissa V Rodriguez, MD
Phone
310-601-3366
Email
lrodriguez@med.usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason J Kutch, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90049
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason J Kutch, PhD
Phone
323-442-2932
Email
kutch@usc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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