Brain Targets in Patients With Bladder Emptying Difficulties
Supraspinal Mechanisms Involved in Voiding Dysfunction.
What it found
Met its main goal
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 | ||
| Changes in Brain Activity After Treatment Measured Using Functional MRI | <0.05 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Transcranial Rotating Permanent Magnet Stimulator (TRPMS)
Results by group
Changes in Brain Activity After Treatment Measured Using Functional MRI
Baseline to three weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 2.759234 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.423569 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.000987 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.094914 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.046153 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 2.950705 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.215242 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 2.799833 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.003400 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.317012 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 5.520249 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 5.455663 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.369907 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.578173 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.745239 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 5.683107 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.782596 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.693368 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.913861 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 2.753587 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.373487 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.345939 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.767377 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.684247 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.027731 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.695211 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | -3.990877 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | -4.272436 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | -2.769022 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | -3.345682 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | -2.921264 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | -3.007422 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | -6.306071 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.999096 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.028872 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.425272 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.393749 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.324719 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.313340 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.935463 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 5.257658 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.281283 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.906453 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 5.236864 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.065269 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.129290 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.078387 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.038723 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.274477 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 2.819778 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.072036 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.645947 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.210466 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.637410 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.535679 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.402534 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.136795 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 2.455777 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.053638 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.798942 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.897008 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 2.518869 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.614616 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.324731 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 5.114769 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.184497 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.545515 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.721826 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 5.286532 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.078467 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.512251 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.551130 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.160711 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.181774 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.946584 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.111778 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.140146 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.255678 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.921595 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 4.093221 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.857368 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.188081 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 2.479540 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 3.000530 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | 2.860924 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | -4.078490 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | -3.109341 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | -3.328545 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | -3.971051 BOLD fMRI T-Value | -6.306071–5.683107 | 10 |
p = <0.05
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Subjects With Multiple Sclerosis and Voiding Dysfunction | 11 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Changes in Brain Activity After Treatment Measured Using Functional MRI
Baseline to three weeks
MRI lesionsBladder, bowel and sexual function
Other measures (7)
Changes in Objective Clinical Outcomes Following Treatment
Baseline, after treatment and 4 month follow up
Bladder, bowel and sexual functionChanges in %Post-Void Residual/Bladder Capacity (PVR/BC) Following Treatment
Baseline, after treatment and 4 month follow up
Bladder, bowel and sexual functionChanges in Non-instrumented Uroflow Variable Qmax Following Treatment
Baseline, after treatment and 4 month follow up
Changes in Liverpool Nomogram Following Treatment
Baseline, after treatment and 4 month follow-up
Bladder, bowel and sexual functionChanges in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire
Baseline, after treatment and 4 month follow up
Bladder, bowel and sexual functionChanges in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire
Baseline, after treatment and 4 month follow up
Bladder, bowel and sexual functionQuality of life (reported by participants)Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire
Baseline, after treatment and 4 month follow up
Bladder, bowel and sexual functionQuality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 80
Show the full criteria
Inclusion criteria
Inclusion Criteria for subjects with neurogenic bladder: * Patients with clinical diagnosis of neurogenic bladder * History of any neurologic illness or injury (including but not limited to spinal cord injury, Multiple Sclerosis, Stroke, spina bifida, Parkinson's, major spine surgery) * 18 years or older Specifics for MS patients: Adult female patients with clinically stable MS [Expanded Disability Status Score (EDSS) ≤6.5], with bladder symptoms ≥3 months, will be screened. Patients will be considered to have VD if they have an increased Postvoid Residual (≥ 20% Maximum Cystometric Capacity). Patients who perform self-catheterization will be included in the VD category as well.
Exclusion criteria
Exclusion Criteria for subjects with neurogenic bladder: * Men (for aims 1 and 2 only), anatomical bladder outlet obstruction (anti-incontinence procedures, urethral strictures, or advanced pelvic organ prolapse). Severe debilitating MS, history of seizures, pregnancy or planning to become pregnant, contraindications to MRI, history of augmentation cystoplasty. Patients with active urinary tract infection (UTI) can be treated and subsequently screened for the trial. * Positive urine pregnancy test at enrollment (There are no known risks to a subject's fetus. There is no known teratogenic risk associated with urodynamics or fMRI) - Cognitively impaired patients
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Noninvasive, Individualized Cortical Modulation Using Transcranial Rotating Permanent Magnet Stimulator for Voiding Dysfunction in Women with Multiple Sclerosis: A Pilot Trial.J Urol · 2022
Results
Jang Y, Tran K, Shi Z, Christof K, Choksi D, Salazar BH, Lincoln JA, Khavari R. Predictors for outcomes of noninvasive, individualized transcranial magnetic neuromodulation in multiple sclerosis women with neurogenic voiding dysfunction. Continence (Amst). 2022 Dec;4:100517. doi: 10.1016/j.cont.2022.100517. Epub 2022 Oct 19.Results
Shi Z, Karmonik C, Soltes A, Tran K, Lincoln JA, Boone T, Khavari R. Altered bladder-related brain network in multiple sclerosis women with voiding dysfunction. Neurourol Urodyn. 2022 Sep;41(7):1612-1619. doi: 10.1002/nau.25008. Epub 2022 Jul 17.Results
Tran K, Shi Z, Karmonik C, John B, Rajab H, Helekar SA, Boone T, Khavari R. Therapeutic effects of non-invasive, individualized, transcranial neuromodulation treatment for voiding dysfunction in multiple sclerosis patients: study protocol for a pilot clinical trial. Pilot Feasibility Stud. 2021 Mar 24;7(1):83. doi: 10.1186/s40814-021-00825-z.Background
Panicker JN, Fowler CJ, Kessler TM. Lower urinary tract dysfunction in the neurological patient: clinical assessment and management. Lancet Neurol. 2015 Jul;14(7):720-32. doi: 10.1016/S1474-4422(15)00070-8.Background
Kuhtz-Buschbeck JP, Gilster R, van der Horst C, Hamann M, Wolff S, Jansen O. Control of bladder sensations: an fMRI study of brain activity and effective connectivity. Neuroimage. 2009 Aug 1;47(1):18-27. doi: 10.1016/j.neuroimage.2009.04.020. Epub 2009 Apr 14.Background
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History
Started
Jul 2018
Main results due
Jul 2021
Finished
Jul 2022
Results posted
Oct 2023
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