Brain Targets in Patients With Bladder Emptying Difficulties
Condition: Neurogenic Bladder; Multiple Sclerosis; Voiding Dysfunction
MeSH terms: Multiple Sclerosis; Urinary Bladder, Neurogenic
Study type: Interventional

Summary: 
      The goal of this study is to identify brain centers specifically associated with "initiation
      of voiding" in patients with neurogenic bladder dysfunction. Currently there is no study that
      has evaluated brain centers involved in initiation of voiding in patients with neurogenic
      voiding dysfunction.

      Patients with neurogenic bladder secondary to etiologies such as Multiple Sclerosis,
      Parkinson's disease, and Cerebrovascular accidents will be recruited in this study. Patients
      will be categorized into 2 groups, those who have trouble emptying their bladder and those
      who urinate appropriately. Our existing and unique functional magnetic resonance imaging
      (fMRI)/ urodynamics (UDS) platform is an ideal platform to identify brain regions involved in
      bladder emptying disorders as seen in patients with neurogenic bladder dysfunction and will
      be used for this study. After characterizing brain regions involved in bladder emptying, the
      investigator propose to use noninvasive transcutaneous magnetic stimulation in a subset of
      patients with voiding dysfunction in aim 3.
    

Detailed description: 
      Difficulty in bladder emptying (Voiding dysfunction,VD) is a costly urinary condition that
      leads to urinary tract infections/stones, sepsis, bladder loss, and permanent kidney damage.
      VD can be present in patients with or without neurologic/brain disorders. Currently the only
      available therapies for VD include bladder catheters or intermittent self-catheterization.
      Catheterization is a burden especially in patients with nerve damage, hand skills may be
      limited. The cost and morbid side effects of catheterizations in patients (blood in the
      urine, pain, trauma, strictures, and infections) requires investigators to develop new
      therapies that are beyond the bladder. Such new therapies could target the brain (where
      bladder control is located).

      In this proposal, investigators plan to further characterize the brain regions involved in
      bladder emptying for each patient and ,perform brain modulation, targeting these regions as a
      possible therapy for VD.

      Patients with bladder dysfunction will be divided into two groups: Group 1: patients with VD;
      and Group 2: patients without VD. Specific Aim 1: To evaluate brain pattern in both groups
      and compare them to each other at the time of bladder emptying. Specific Aim 2: To evaluate
      reliability of the nerve fibers in the brain and see whether damage to these fibers is
      related to difficulty emptying the bladder. Specific Aim 3: To perform non-invasive brain
      stimulation on specific regions of the brain responsible for bladder control to improve
      bladder emptying.

      This study is an interventional Study: The investigators have completed a well-powered study
      on twenty-seven female MS patients during their bladder storage phase. Aims 1 and 2 use the
      data from previously completed trial and investigators will perform additional imaging
      analysis on it. Aim 3 is a new and small trial in which investigators planned to modulate the
      regions of the brain that are related to bladder control.

      Approximately 16 study participants will be enrolled at Houston Methodist, and 16 throughout
      the study.
    

Intervention name(s): Transcranial Rotating Permanent Magnet Stimulator (TRPMS)
Intervention type(s): Device
Intervention description(s): TRPMS is a wearable non-invasive transcranial rotating permanent magnet stimulator. It has been determined to be a Non Significant Risk device by the FDA.
The amount and frequency of therapy are prescribed by the physician, and the device is custom configured to the patient to deliver the required amount of treatment. The device does not turn on until it is time for the treatment. It consists of three main parts: Neoprene cap with microstimulator(s), stimulator console (device controller box) and the tablet with TRPMS app which activates the console. The neoprene cap prevents the microstimulator(s) from coming in direct contact with the scalp. Microstimulators deliver the magnetic stimulation to the brain based on a prescription program uploaded in the stimulator controller.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neurogenic bladder; Functional Neuroimaging; Transcranial Rotating Permanent Magnet Stimulator (TRPMS)