TY - JOUR
T1 - Noninvasive, Individualized Cortical Modulation Using Transcranial Rotating Permanent Magnet Stimulator for Voiding Dysfunction in Women with Multiple Sclerosis
T2 - A Pilot Trial
AU - Khavari, Rose
AU - Tran, Khue
AU - Helekar, Santosh A.
AU - Shi, Zhaoyue
AU - Karmonik, Christof
AU - Rajab, Hamida
AU - John, Blessy
AU - Jalali, Ali
AU - Boone, Timothy
N1 - Funding Information:
Funding: This is an investigator-initiated trial by Dr. Rose Khavari. Dr. Rose Khavari is partially supported by K23DK118209, by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK, NIH) and Houston Methodist Clinician Scientist Program. Sponsored by the Methodist Hospital System. Funder and sponsor have no ultimate authority over the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Publisher Copyright:
© 2022 Lippincott Williams and Wilkins. All rights reserved.
PY - 2022/3/1
Y1 - 2022/3/1
N2 - Purpose:Voiding dysfunction (VD) leading to urinary retention is a common neurogenic lower urinary tract symptom in patients with multiple sclerosis (MS). Currently, the only effective management for patients with MS with VD is catheterization. Transcranial Rotating Permanent Magnet Stimulator (TRPMS) is a noninvasive, portable, multifocal neuromodulator that simultaneously modulates multiple cortical regions and the strength of their functional connections. In this pilot trial (ClinicalTrials.gov Identifier: NCT03574610), we investigated the safety and therapeutic effects of TRPMS in modulating brain regions of interest (ROIs) engaged with voiding initiation to improve VD in MS women.Materials and Methods:Ten MS women with VD (having % post-void residual/bladder capacity [%PVR/BC] ≥40% or being in the lower 10th percentile of the Liverpool nomogram) underwent concurrent functional magnetic resonance imaging/urodynamic study (fMRI/UDS) with 3 cycles of bladder filling/emptying, at baseline and post-treatment. Predetermined ROIs and their activations at voiding initiation were identified on patients' baseline fMRI/UDS scans, corresponding to microstimulator placement. Patients received 10 consecutive 40-minute treatment sessions. Brain activation group analysis, noninstrumented uroflow, and validated questionnaires were compared at baseline and post-treatment.Results:No treatment-related adverse effects were reported. Post-treatment, patients showed significantly increased activation in regions known to be involved at voiding initiation in healthy subjects. %PVR/BC significantly decreased. Significant improvement of bladder emptying symptoms were reported by patients via validated questionnaires.Conclusions:Both neuroimaging and clinical data suggested TRPMS effectively and safely modulated brain regions that are involved in the voiding phase of the micturition cycle, leading to clinical improvements in bladder emptying in patients with MS.
AB - Purpose:Voiding dysfunction (VD) leading to urinary retention is a common neurogenic lower urinary tract symptom in patients with multiple sclerosis (MS). Currently, the only effective management for patients with MS with VD is catheterization. Transcranial Rotating Permanent Magnet Stimulator (TRPMS) is a noninvasive, portable, multifocal neuromodulator that simultaneously modulates multiple cortical regions and the strength of their functional connections. In this pilot trial (ClinicalTrials.gov Identifier: NCT03574610), we investigated the safety and therapeutic effects of TRPMS in modulating brain regions of interest (ROIs) engaged with voiding initiation to improve VD in MS women.Materials and Methods:Ten MS women with VD (having % post-void residual/bladder capacity [%PVR/BC] ≥40% or being in the lower 10th percentile of the Liverpool nomogram) underwent concurrent functional magnetic resonance imaging/urodynamic study (fMRI/UDS) with 3 cycles of bladder filling/emptying, at baseline and post-treatment. Predetermined ROIs and their activations at voiding initiation were identified on patients' baseline fMRI/UDS scans, corresponding to microstimulator placement. Patients received 10 consecutive 40-minute treatment sessions. Brain activation group analysis, noninstrumented uroflow, and validated questionnaires were compared at baseline and post-treatment.Results:No treatment-related adverse effects were reported. Post-treatment, patients showed significantly increased activation in regions known to be involved at voiding initiation in healthy subjects. %PVR/BC significantly decreased. Significant improvement of bladder emptying symptoms were reported by patients via validated questionnaires.Conclusions:Both neuroimaging and clinical data suggested TRPMS effectively and safely modulated brain regions that are involved in the voiding phase of the micturition cycle, leading to clinical improvements in bladder emptying in patients with MS.
KW - magnetic resonance imaging
KW - multiple sclerosis
KW - Neuroimaging
KW - Humans
KW - Middle Aged
KW - Transcranial Magnetic Stimulation/methods
KW - Multiple Sclerosis/diagnostic imaging
KW - Urodynamics
KW - Magnetic Resonance Imaging
KW - Pilot Projects
KW - Adult
KW - Female
KW - Aged
KW - Urinary Bladder, Neurogenic/physiopathology
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UR - http://www.scopus.com/inward/citedby.url?scp=85120782519&partnerID=8YFLogxK
U2 - 10.1097/JU.0000000000002297
DO - 10.1097/JU.0000000000002297
M3 - Article
C2 - 34694911
SN - 0022-5347
VL - 207
SP - 657
EP - 668
JO - The Journal of urology
JF - The Journal of urology
IS - 3
ER -