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Neuromodulation

Non-Invasive Brain Stimulation for Neurogenic Bladder in MS (MSBLADDER Trial)

N/A

Recruiting

Led By Rose Khavari, MD

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least one bladder storage symptom (e.g., urinary frequency, urinary urgency, nocturia with or without incontinence) indicated by OAB-AT≥ 8

Adult women (≥ 18 years of age)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 week after, 1 month after and 3 months after rtms treatment

Awards & highlights

MSBLADDER Trial Summary

This trial is studying the effects of a non-invasive brain stimulation therapy (rTMS) on overactive bladder symptoms in people with multiple sclerosis (MS). The results of this study could provide a promising new approach to MS bladder control.

Who is the study for?

This trial is for adult women with Multiple Sclerosis (MS) who have stable MS symptoms and experience overactive bladder issues. They must not be pregnant, planning to become pregnant, or nursing, and should not have a history of certain mental health conditions or be on medications that could worsen these conditions.Check my eligibility

What is being tested?

The study tests the effects of repetitive Transcranial Magnetic Stimulation (rTMS), a noninvasive brain therapy aimed at improving bladder control in women with MS. Participants will undergo treatment sessions after an initial screening and functional MRI scan to locate target brain regions.See study design

What are the potential side effects?

Preliminary data suggests no treatment-related adverse effects from rTMS. However, as it's a noninvasive procedure modulating brain activity, potential side effects might include mild headaches or scalp discomfort during application.

MSBLADDER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience frequent urination, urgency, or need to urinate at night.

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I am a woman aged 18 or older.

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I had a UTI, but it's treated and my latest urine test was clear.

MSBLADDER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 week after, 1 month after and 3 months after rtms treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 week after, 1 month after and 3 months after rtms treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week after, 1 month after and 3 months after rtms treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in subjective clinical outcomes following treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire

Changes on patient reported outcomes following treatment - 2 day bladder diary

Secondary outcome measures

Changes in %Post-Void Residual/Bladder Capacity (PVR/BC) following treatment

Changes in brain activation patterns following rTMS treatment - functional MRI imaging

Changes in objective clinical outcomes following treatment - Bladder Capacity

Other outcome measures

Changes in subjective clinical outcomes following treatment - American Urological Association Symptom Score (AUASS) Questionnaire

Changes in subjective clinical outcomes following treatment - Incontinence Impact Questionnaire Short Form (IIQ-7)

Changes in subjective clinical outcomes following treatment - Overactive Bladder (OAB) Awareness Tool

MSBLADDER Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active rTMSActive Control1 Intervention

1 Hz (LF) and 10 Hz (HF) rTMS stimulation will be delivered at 90% of the resting motor threshold for 40 min each week day for two weeks.

Group II: Sham rTMSPlacebo Group1 Intervention

Low-frequency (1Hz) active rTMS stimulation will be delivered with an inert "sham" stimulation coil for 40 min each week day for two weeks.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

274 Previous Clinical Trials

80,506 Total Patients Enrolled

3 Trials studying Multiple Sclerosis

49 Patients Enrolled for Multiple Sclerosis

Rose Khavari, MDPrincipal InvestigatorThe Methodist Hospital Research Institute

9 Previous Clinical Trials

497 Total Patients Enrolled

2 Trials studying Multiple Sclerosis

39 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity to join this trial for participants yet?

"Affirmative. Per the information on clinicaltrials.gov, this clinical trial is still searching for participants - it was initially posted on March 30th 2023 and subsequently modified October 3rd of that same year. A total of 29 individuals must be enrolled at a single medical facility."

Answered by AI

What is the current enrollment of participants in this research?

"Affirmative. The clinicaltrials.gov database reveals that this experiment, which was initially introduced on March 30th 2023, is actively recruiting participants. Currently they are looking for 29 individuals from a single centre to join the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neuromodulating Cortical Regions Involved in Neurogenic Bladder in MS

Rose Khavari, M.D. 2023. "Neuromodulating Cortical Regions Involved in Neurogenic Bladder in MS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06072703.

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