Trial Outcomes & Findings for Brain Targets in Patients With Bladder Emptying Difficulties (NCT NCT03574610)
NCT ID: NCT03574610
Last Updated: 2023-10-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Baseline to three weeks
Results posted on
2023-10-05
Participant Flow
Participant milestones
| Measure |
Subjects With Multiple Sclerosis and Voiding Dysfunction
Subjects with Multiple Sclerosis (MS) and voiding dysfunction (VD). In this group 'Transcranial Rotating Permanent Magnet Stimulator (TRPMS)' device will be used.
Transcranial Rotating Permanent Magnet Stimulator (TRPMS): 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.
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|---|---|
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Overall Study
STARTED
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11
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brain Targets in Patients With Bladder Emptying Difficulties
Baseline characteristics by cohort
| Measure |
Subjects With Multiple Sclerosis and Voiding Dysfunction
n=10 Participants
Subjects with Multiple Sclerosis (MS) and voiding dysfunction (VD). In this group 'Transcranial Rotating Permanent Magnet Stimulator (TRPMS)' device will be used.
Transcranial Rotating Permanent Magnet Stimulator (TRPMS): 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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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9 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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1 Participants
n=5 Participants
|
|
Age, Continuous
|
53.40 Years
n=5 Participants
|
|
Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Number of participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to three weeksPopulation: Eleven patients were eligible and consented to participate. One withdrew before baseline scan, and 10 received the treatment and completed all their scans and assessments (July 2019 - December 2020) and were included in the analysis. Amongst 8 patients who completed their 4-month follow-ups, 1 could not return for an in-person visit and only her validated questionnaires were collected.
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.
Outcome measures
| Measure |
Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis
n=10 Participants
Transcranial Rotating Permanent Magnet Stimulator (TRPMS): 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.
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|---|---|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L superior frontal gyrus
|
2.455777 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R superior frontal gyrus
|
3.053638 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong desire to void: L inferior frontal gyrus
|
2.759234 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong desire to void: L superior temporal gyrus
|
3.423569 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong desire to void: L inferior temporal gyrus
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3.000987 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong desire to void: L middle temporal gyrus
|
3.094914 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong desire to void: R middle temporal gyrus
|
4.046153 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong desire to void: L inferior parietal lobule
|
2.950705 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong desire to void: R inferior parietal lobule
|
4.215242 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong desire to void: R paracentral lobule
|
2.799833 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong desire to void: R superior parietal lobule
|
4.003400 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: R supplementary motor area
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4.317012 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: L postcentral gyrus
|
5.520249 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: R postcentral gyrus
|
5.455663 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: L angular gyrus
|
3.369907 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: R supramarginal gyrus
|
4.578173 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: L superior medial gyrus
|
3.745239 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: L inferior occipital gyrus
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5.683107 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: L middle cingulate cortex
|
3.782596 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: R middle cingulate cortex
|
3.693368 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: R posterior cingulate cortex
|
3.913861 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: L thalamus
|
2.753587 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: R thalamus
|
3.373487 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: L precuneus
|
4.345939 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: R precuneus
|
3.767377 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: L caudate nucleus
|
4.684247 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: L hippocampus
|
3.027731 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: L putamen
|
3.695211 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: L precentral gyrus
|
-3.990877 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: R precentral gyrus
|
-4.272436 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: L insula lobe
|
-2.769022 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: L superior frontal gyrus
|
-3.345682 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: L middle frontal gyrus
|
-2.921264 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: R cerebellum
|
-3.007422 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Strong Desire to void: R fusiform gyrus
|
-6.306071 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L postcentral gyrus
|
4.999096 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R postcentral gyrus
|
4.028872 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L precentral gyrus
|
4.425272 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R precentral gyrus
|
4.393749 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L superior temporal gyrus
|
3.324719 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R superior temporal gyrus
|
3.313340 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L middle temporal gyrus
|
4.935463 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R middle temporal gyrus
|
5.257658 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L inferior temporal gyrus
|
4.281283 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L supramarginal gyrus
|
3.906453 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R supramarginal gyrus
|
5.236864 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L inferior occipital gyrus
|
3.065269 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R superior occipital gyrus
|
4.129290 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R middle occipital gyrus
|
4.078387 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L inferior frontal gyrus (p. Orbitalis)
|
4.038723 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L inferior frontal gyrus (p. Triangularis)
|
4.274477 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L inferior frontal gyrus (p. Opercularis)
|
2.819778 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R inferior frontal gyrus (p. Orbitalis)
|
3.072036 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R inferior frontal gyrus (p. Triangularis)
|
3.645947 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L cerebellum
|
4.210466 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L rectal gyrus
|
4.637410 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
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Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R rectal gyrus
|
3.535679 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L superior medial gyrus
|
3.402534 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R superior medial gyrus
|
3.136795 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L middle frontal gyrus
|
3.798942 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R middle frontal gyrus
|
3.897008 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L supplementary motor area
|
2.518869 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R supplementary motor area
|
4.614616 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L paracentral lobule
|
3.324731 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R paracentral lobule
|
5.114769 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R superior parietal lobule
|
4.184497 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R inferior parietal lobule
|
4.545515 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L superior orbital gyrus
|
3.721826 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L middle orbital gyrus
|
5.286532 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R middle orbital gyrus
|
3.078467 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R calcarine gyrus
|
3.512251 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L calcarine gyrus
|
3.551130 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L anterior cingulate cortex
|
4.160711 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L middle cingulate cortex
|
3.181774 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R middle cingulate cortex
|
3.946584 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R angular gyrus
|
4.111778 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L thalamus
|
3.140146 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R thalamus
|
3.255678 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L precuneus
|
4.921595 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R precuneus
|
4.093221 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R caudate nucleus
|
3.857368 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L putamen
|
3.188081 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L amygdala
|
2.479540 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R insula lobe
|
3.000530 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L rolandic operculum
|
2.860924 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: L hippocampus
|
-4.078490 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R hippocampus
|
-3.109341 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R fusiform gyrus
|
-3.328545 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
|
Changes in Brain Activity After Treatment Measured Using Functional MRI
Voiding initiation: R rolandic operculum
|
-3.971051 BOLD fMRI T-Value
Interval -6.306071 to 5.683107
|
SECONDARY outcome
Timeframe: Baseline, after treatment and 4 month follow upPopulation: Eleven patients were eligible and consented to participate. One withdrew before baseline scan, and 10 received the treatment and completed all their scans and assessments (July 2019 - December 2020) and were included in the analysis. Amongst 8 patients who completed their 4-month follow-ups, 1 could not return for an in-person visit and only her validated questionnaires were collected.
The objective clinical assessment included changes in post void residual (PVR), voided volume (VV) and bladder capacity (BC) in participants after treatment as compared to baseline. PVR measures the volume of urine (cc/mL) that is left after voiding. VV measures the volume of urine that is voided (cc/mL). BC measures the volume of urine (cc/mL) the bladder has a capacity to hold, this value is calculated by adding the VV + PVR values obtained.
Outcome measures
| Measure |
Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis
n=10 Participants
Transcranial Rotating Permanent Magnet Stimulator (TRPMS): 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.
|
|---|---|
|
Changes in Objective Clinical Outcomes Following Treatment
Voided volume baseline
|
188.1 mL
Standard Deviation 112.21
|
|
Changes in Objective Clinical Outcomes Following Treatment
Voided volume post-treatment
|
218.80 mL
Standard Deviation 110.12
|
|
Changes in Objective Clinical Outcomes Following Treatment
Voided volume 4 month follow-up
|
189.88 mL
Standard Deviation 106.32
|
|
Changes in Objective Clinical Outcomes Following Treatment
PVR baseline
|
193.10 mL
Standard Deviation 83.46
|
|
Changes in Objective Clinical Outcomes Following Treatment
PVR post-treatment
|
98.70 mL
Standard Deviation 89.37
|
|
Changes in Objective Clinical Outcomes Following Treatment
PVR 4 month follow-up
|
160.70 mL
Standard Deviation 142.93
|
|
Changes in Objective Clinical Outcomes Following Treatment
Bladder capacity baseline
|
381.20 mL
Standard Deviation 152.37
|
|
Changes in Objective Clinical Outcomes Following Treatment
Bladder capacity post-treatment
|
317.50 mL
Standard Deviation 144.11
|
|
Changes in Objective Clinical Outcomes Following Treatment
Bladder capacity 4 month follow-up
|
350.63 mL
Standard Deviation 226.32
|
SECONDARY outcome
Timeframe: Baseline, after treatment and 4 month follow upPopulation: Eleven patients were eligible and consented to participate. One withdrew before baseline scan, and 10 received the treatment and completed all their scans and assessments (July 2019 - December 2020) and were included in the analysis. Amongst 8 patients who completed their 4-month follow-ups, 1 could not return for an in-person visit and only her validated questionnaires were collected.
Objective clinical assessments included changes in post void residual (PVR) and bladder capacity in participants after treatment. PVR measures the volume of urine (cc/mL) that is left after voiding. BC measures the volume of urine (cc/mL) the bladder has a capacity to hold. % PVR/BC measures how much of the overall volume is left after voiding, showing how efficient a voiding is before and after treatment.
Outcome measures
| Measure |
Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis
n=10 Participants
Transcranial Rotating Permanent Magnet Stimulator (TRPMS): 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.
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|---|---|
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Changes in %Post-Void Residual/Bladder Capacity (PVR/BC) Following Treatment
%PVR/BC (at baseline)
|
54.04 Percentage
Standard Deviation 17.48
|
|
Changes in %Post-Void Residual/Bladder Capacity (PVR/BC) Following Treatment
%PVR/BC (post-treatment)
|
29.46 Percentage
Standard Deviation 22.08
|
|
Changes in %Post-Void Residual/Bladder Capacity (PVR/BC) Following Treatment
%PVR/BC (at 4 month follow-up)
|
42.08 Percentage
Standard Deviation 18.97
|
SECONDARY outcome
Timeframe: Baseline, after treatment and 4 month follow upPopulation: Eleven patients were eligible and consented to participate. One withdrew before baseline scan, and 10 received the treatment and completed all their scans and assessments (July 2019 - December 2020) and were included in the analysis. Amongst 8 patients who completed their 4-month follow-ups, 1 could not return for an in-person visit and only her validated questionnaires were collected.
The objective clinical assessment included changes in non-instrumented uroflow variables such as Qmax, in participants after treatment as compared to baseline. Qmax values reported here correspond to the peak urine flow (mL/s) seen during uroflowmetry testing.
Outcome measures
| Measure |
Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis
n=10 Participants
Transcranial Rotating Permanent Magnet Stimulator (TRPMS): 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.
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|---|---|
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Changes in Non-instrumented Uroflow Variable Qmax Following Treatment
Qmax at baseline
|
22.2 mL/sec
Standard Deviation 14.76
|
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Changes in Non-instrumented Uroflow Variable Qmax Following Treatment
Qmax post-treatment
|
31.00 mL/sec
Standard Deviation 15.17
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|
Changes in Non-instrumented Uroflow Variable Qmax Following Treatment
Qmax at 4 month follow-up
|
25.50 mL/sec
Standard Deviation 14.25
|
SECONDARY outcome
Timeframe: Baseline, after treatment and 4 month follow-upPopulation: Eleven patients were eligible and consented to participate. One withdrew before baseline scan, and 10 received the treatment and completed all their scans and assessments (July 2019 - December 2020) and were included in the analysis. Amongst 8 patients who completed their 4-month follow-ups, 1 could not return for an in-person visit and only her validated questionnaires were collected.
The objective clinical assessment included changes in non-instrumented uroflow variables such as Liverpool nomogram in participants after treatment as compared to baseline. The Liverpool nomogram provides normal reference ranges for the maximum and average urine flow rates over a wide range of voided volumes. It is presented as a percentile ranking depending on the flow rate and voided volume for each participant.
Outcome measures
| Measure |
Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis
n=10 Participants
Transcranial Rotating Permanent Magnet Stimulator (TRPMS): 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.
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|---|---|
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Changes in Liverpool Nomogram Following Treatment
Liverpool Nomogram baseline
|
34.00 Percentile
Standard Deviation 36.12
|
|
Changes in Liverpool Nomogram Following Treatment
Liverpool Nomogram post-treatment
|
62.80 Percentile
Standard Deviation 32.90
|
|
Changes in Liverpool Nomogram Following Treatment
Liverpool Nomogram 4 month follow-up
|
49.63 Percentile
Standard Deviation 36.23
|
SECONDARY outcome
Timeframe: Baseline, after treatment and 4 month follow upPopulation: Eleven patients were eligible and consented to participate. One withdrew before baseline scan, and 10 received the treatment and completed all their scans and assessments (July 2019 - December 2020) and were included in the analysis. Amongst 8 patients who completed their 4-month follow-ups, 1 could not return for an in-person visit and only her validated questionnaires were collected.
Our subjective clinical assessment included changes in validated questionnaires. This assessment has 6 questions and is used to assess life quality and symptom distress for urinary incontinence in women. We report raw scores here for questions pertaining to voiding symptoms. Each question has the following score range: 0-4 (with the highest score associated with worse symptoms).
Outcome measures
| Measure |
Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis
n=10 Participants
Transcranial Rotating Permanent Magnet Stimulator (TRPMS): 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.
|
|---|---|
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Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire
UDI-6 Q1 baseline
|
3.10 Score on a scale
Standard Deviation 1.45
|
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Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire
UDI-6 Q1 post-treatment
|
2.70 Score on a scale
Standard Deviation 1.25
|
|
Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire
UDI-6 Q1 4 month follow-up
|
1.88 Score on a scale
Standard Deviation 1.46
|
|
Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire
UDI-6 Q2 baseline
|
2.50 Score on a scale
Standard Deviation 1.51
|
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Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire
UDI-6 Q2 post-treatment
|
2.20 Score on a scale
Standard Deviation 1.48
|
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Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire
UDI-6 Q2 4 month follow-up
|
1.50 Score on a scale
Standard Deviation 1.20
|
|
Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire
UDI-6 Q5 baseline
|
3.30 Score on a scale
Standard Deviation 1.06
|
|
Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire
UDI-6 Q5 post-treatment
|
2.20 Score on a scale
Standard Deviation 1.55
|
|
Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire
UDI-6 Q5 4 month follow-up
|
1.38 Score on a scale
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Baseline, after treatment and 4 month follow upPopulation: Eleven patients were eligible and consented to participate. One withdrew before baseline scan, and 10 received the treatment and completed all their scans and assessments (July 2019 - December 2020) and were included in the analysis. Amongst 8 patients who completed their 4-month follow-ups, 1 could not return for an in-person visit and only her validated questionnaires were collected.
Our subjective clinical assessment included changes in validated questionnaires. This assessment has 8 questions and is used to assess how bothersome urinary symptoms are and quality of life. We report raw scores here for questions pertaining to voiding symptoms. Questions 1-7 have the following score range: 0-5 (with the highest score associated with worse symptoms). The last question pertains to quality of life and has a score range of: 0-6 (with the highest score associated with very reduced quality of life).
Outcome measures
| Measure |
Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis
n=10 Participants
Transcranial Rotating Permanent Magnet Stimulator (TRPMS): 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.
|
|---|---|
|
Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire
AUSS Q3 baseline
|
4.30 Score on a scale
Standard Deviation 1.57
|
|
Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire
AUSS Q3 post-treatment
|
2.90 Score on a scale
Standard Deviation 1.52
|
|
Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire
AUSS Q3 4 month follow-up
|
3.00 Score on a scale
Standard Deviation 1.77
|
|
Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire
AUSS Q5 baseline
|
2.60 Score on a scale
Standard Deviation 1.84
|
|
Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire
AUSS Q5 post-treatment
|
2.30 Score on a scale
Standard Deviation 1.89
|
|
Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire
AUSS Q5 4 month follow-up
|
1.88 Score on a scale
Standard Deviation 1.73
|
|
Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire
AUSS Q7 baseline
|
2.80 Score on a scale
Standard Deviation 1.14
|
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Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire
AUSS Q7 post-treatment
|
2.20 Score on a scale
Standard Deviation 0.92
|
|
Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire
AUSS Q7 4 month follow-up
|
2.13 Score on a scale
Standard Deviation 1.36
|
|
Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire
AUSS Q8 baseline
|
4.20 Score on a scale
Standard Deviation 1.69
|
|
Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire
AUSS Q8 post-treatment
|
3.50 Score on a scale
Standard Deviation 1.35
|
|
Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire
AUSS Q8 4 month follow-up
|
2.75 Score on a scale
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: Baseline, after treatment and 4 month follow upPopulation: Eleven patients were eligible and consented to participate. One withdrew before baseline scan, and 10 received the treatment and completed all their scans and assessments (July 2019 - December 2020) and were included in the analysis. Amongst 8 patients who completed their 4-month follow-ups, 1 could not return for an in-person visit and only her validated questionnaires were collected.
Our subjective clinical assessment included changes in validated questionnaires. This assessment has 24 questions that measure bladder symptoms across 3 different domains: incontinence (score range: 0-29), storage and voiding (score range: 0-22), and consequences (score range: 0-23); the highest score is associated with worse symptoms. The last question focuses on quality of life scored from 0 (pleased) to 4 (unhappy). We report raw scores here for all domains and QoL.
Outcome measures
| Measure |
Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis
n=10 Participants
Transcranial Rotating Permanent Magnet Stimulator (TRPMS): 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.
|
|---|---|
|
Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire
NBSS (Incontinence) baseline
|
11.70 Score on a scale
Standard Deviation 5.91
|
|
Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire
NBSS (Incontinence) post-treatment
|
9.00 Score on a scale
Standard Deviation 6.11
|
|
Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire
NBSS (Incontinence) 4 month follow-up
|
9.88 Score on a scale
Standard Deviation 6.15
|
|
Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire
NBSS (Storage and Voiding) baseline
|
15.00 Score on a scale
Standard Deviation 2.62
|
|
Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire
NBSS (Storage and Voiding) post-treatment
|
14.10 Score on a scale
Standard Deviation 2.56
|
|
Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire
NBSS (Storage and Voiding) 4 month follow-up
|
11.88 Score on a scale
Standard Deviation 2.17
|
|
Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire
NBSS (Consequences) baseline
|
5.00 Score on a scale
Standard Deviation 2.05
|
|
Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire
NBSS (Consequences) post-treatment
|
4.60 Score on a scale
Standard Deviation 2.50
|
|
Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire
NBSS (Consequences) 4 month follow-up
|
5.63 Score on a scale
Standard Deviation 1.06
|
|
Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire
NBSS (QoL) baseline
|
2.80 Score on a scale
Standard Deviation 1.32
|
|
Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire
NBSS (QoL) post-treatment
|
2.10 Score on a scale
Standard Deviation 1.10
|
|
Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire
NBSS (QoL) 4 month follow-up
|
1.50 Score on a scale
Standard Deviation 1.31
|
Adverse Events
Subjects With Multiple Sclerosis and Voiding Dysfunction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place