Pilot Study: Apllicability of an fMRI Protocol for Incontinence Research
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Activated brain regions demonstrating brain activity
研究概览
简要总结
Urinary incontinence is the most frequently observed lower urinary tract symptom (LUTS) in children with cerebral palsy (CP) (Samijn et al., 2016).
Higher brain centers responsible for bladder function may be related to the presence of incontinence.
The current pilot study is the first study of a research project focusing on correlations between brain damage and incontinence.
详细描述
Urinary incontinence is the most frequently observed lower urinary tract symptom (LUTS) in children with cerebral palsy (CP) (Samijn et al., 2016). Being more or completely dry could improve the quality of life and health status of the child and the social environment.
Higher brain centers responsible for bladder function may be related to the presence of incontinence. These higher brain centers could be correlated to the brain damage seen in children with CP.
The current pilot study is the first study of a research project focusing on correlations between brain damage and incontinence. The study wants to validate if the defined fMRI paradigm can provide correct information concerning brain activity during bladder filling, to ensure usable results and comply with ethical demands for testing in children, the protocol will be tested and results validated during the pilot study with healthy adults. During the fMRI study, the bladder will be filled until FSF and NDV. Functional MRI-data will be obtained during the filling and emptying phase of the bladder on both volumes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults
排除标准
- •lower or upper urinary tract dysfunction
结局指标
主要结局
Activated brain regions demonstrating brain activity
时间窗: through study completion, an average of 6 weeks
fMRI brain imaging data will be analyzed using FMRIB Software Library v6.0 (FSL).
次要结局
未报告次要终点
