Higher Neural and Clinical Effects of Non-Invasive Transcranial Neuromodulation in Adults With Overactive Bladder

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Overactive bladder (OAB) imposes a significant quality of life, mental health, and economic burdens. OAB with or without Urgency incontinence is associated with depression, sexual dysfunction, and limitation of social interactions and physical activities, which significantly affects quality of life. Non-invasive neuromodulation with repetitive transcranial magnetic stimulation (rTMS) can be used in research settings to investigate responses to focal regional brain activation. In the clinical setting, rTMS normalizes brain activity with associated clinical benefits in conditions such as refractory depression. rTMS has been studied for effects on lower urinary tract symptoms (LUTS) in bladder pain and neurogenic lower urinary tract symptoms (LUTS) populations. Unlike many standard of care OAB interventions, the safety of rTMS is well-reported, including for use in elderly populations and those with cognitive impairment. Functional magnetic resonance imaging (fMRI) to evaluate neuroplasticity is emerging as an essential tool to define OAB phenotypes; however, phenotyping studies guided by mechanistic data are lacking. The effects of central neuromodulation on regions involved OAB mechanisms and associated physiological and clinical responses are unknown. This study will be the first to report neuroplasticity, physiologic, and clinical effects of central neuromodulation with rTMS in adults with OAB.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• Females \& Males

• 40 to 80 years old

• 3 months of OAB symptoms without active urinary tract infection currently

• Bladder diary:

‣ Mean voids/24 hours ≥ 8.0

⁃ Mean urgency episodes/24 hours ≥ 3.0

• Montreal Cognitive Assessment (MoCA) score \>10

Locations
United States
Texas
Houston Methodist Hospital
RECRUITING
Houston
Contact Information
Primary
Michelle Almarez, BBA
almarez@houstonmethodist.org
713-441-5920
Time Frame
Start Date: 2024-01-08
Estimated Completion Date: 2026-07
Participants
Target number of participants: 10
Treatments
Experimental: Transcranial magnetic stimulation
All study subjects undergo five sessions of rTMS. The 40-minute sessions target the supplemental motor area (inhibitory stimulation) and prefrontal cortex (excitatory stimulation)
Related Therapeutic Areas
Sponsors
Leads: The Methodist Hospital Research Institute

This content was sourced from clinicaltrials.gov