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NCT03574610 · ClinicalTrials.gov registry record · NA

Brain Targets in Patients With Bladder Emptying Difficulties

A NA study, sponsored by The Methodist Hospital Research Institute.

Completed
Registry status
NA
Development phase
11
Enrollment target

NCT03574610: Completed NA study, sponsored by The Methodist Hospital Research Institute.

NCT03574610 is a NA study that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03574610, a NA study, has completed, sponsored by The Methodist Hospital Research Institute.

COMPLETED
Registry status
NA
Development phase
11 participants
Enrollment target

Study 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.

Primary Outcome

Here we measured changes in brain activation in modulated brain regions of interest (ROI) via blood oxygen level-dependent (BOLD) signals during "strong desire to void" and "voiding initiation (attempt)". We determined if there was a significant increase or decrease in activity (voxel signal) after treatment using the following criteria: 1) increase in activation was defined as T-value greater than 2.074 and 2) decrease in activation was defined as T-value less than 2.074.

Interventions

  • DEVICE Transcranial Rotating Permanent Magnet Stimulator (TRPMS)

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2018-07-01
Est. Completion 2022-07-31
Phase NA

What the finished NCT03574610 record still lists

NCT03574610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Transcranial Rotating Permanent Magnet Stimulator (TRPMS) is the first listed.

NCT03574610 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03574610 about?

NCT03574610 is a clinical study titled "Brain Targets in Patients With Bladder Emptying Difficulties". 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. P...

What is the current status of trial NCT03574610?

This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2018-07-01. Estimated completion is 2022-07-31.

What interventions are being tested in trial NCT03574610?

The interventions under investigation include: Transcranial Rotating Permanent Magnet Stimulator (TRPMS) (DEVICE).

Who is sponsoring clinical trial NCT03574610?

This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03574610's enrollment target sits among peer trials

11 1927th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03574610, the US trial registry maintained by the National Library of Medicine. NCT03574610 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.