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临床试验/NCT05255692
NCT05255692尚未招募不适用

Pilot Study: Apllicability of an fMRI Protocol for Incontinence Research

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2025年5月1日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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