Higher Neural and Clinical Effects of Non-Invasive Transcranial Neuromodulation in Adults With Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Functional connectivity
研究概览
简要总结
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.
详细描述
This prospective trial will enroll eligible adults with OAB recruited from Urology and urogynecology clinics. Subjects have a baseline evaluation with questionnaires, clinical data, and fMRI to assess brain activity during urinary urgency. All subjects receive the intervention: 5 daily sessions of rTMS to regions of interest. Electromyography will assess pelvic floor muscle activity at rest during rTMS. Following the intervention, an evaluation with questionnaires, clinical data, and fMRI is repeated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnant, nursing, or self-report of planning to become pregnant.
- •Contraindication to MRI or to the Rapid2 Magstim Device as listed in the operator manual
- •Qmax < 10 ml/s in males on uroflow
- •< 20th percentile on Liverpool nomogram
- •Postvoid residual volume ≥ 200 mL, suprapubic or indwelling catheter
- •Personal or immediate family history of seizure disorder
- •Taking (bupropion) Wellbutrin or heavy alcohol use
- •Parkinson's disease, Multiple sclerosis, spinal cord injury
- •Intracranial lesions and hemorrhagic stroke within the last 12 months
- •History of interstitial cystitis, pelvic radiation, bladder augmentation
- •Intradetrusor botulinum toxin injections within 6 months
- •Pelvic floor therapy within 2 months.
- •Active/on-mode Sacral nerve stimulator (eligible if turned off)
- •Incarcerated patients
结局指标
主要结局
Functional connectivity
时间窗: Post-intervention at: 0 to 3 days
Connectivity of regions of interest with a full bladder and empty bladder state
Regional brain activity
时间窗: Post-intervention at: 0 to 3 days
Activity in the supplemental motor area and prefrontal cortex during full bladder
次要结局
- Pelvic floor muscle activity(on day 5 of the intervention)
- Urinary frequency(Post-intervention at: 1 day, 3 weeks, 6 weeks)
- Urgency episodes(Post-intervention at: 1 day, 3 weeks, 6 weeks)
- OAB Symptom Bother(Post-intervention at: 1 day, 3 weeks, 6 weeks)
- OAB related Quality of life(Post-intervention at: 1 day, 3 weeks, 6 weeks)