NCT07831044招募中不适用
Analysis of Cerebrospinal Fluid Dynamics in Patients With Normal Pressure Hydrocephalus Using Magnetic Resonance Imaging
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change from Baseline in Cerebrospinal Fluid Flow Velocity (cm/s) at 30 Minutes Post-Procedure
研究概览
简要总结
This study aims to evaluate whether phase-contrast magnetic resonance imaging (MRI)-based cerebrospinal fluid (CSF) flow dynamics can improve the diagnosis and prognostic assessment of normal pressure hydrocephalus (NPH). In addition, the study investigates how changes in CSF flow parameters before and after CSF diversion procedures are associated with clinical improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with clinical symptoms consistent with normal pressure hydrocephalus (presence of gait disturbance accompanied by at least one of the following: cognitive impairment or urinary dysfunction)
- •Evans' ratio ≥ 0.3 on brain MRI
排除标准
- •Patients who cannot undergo CSF drainage due to structural abnormalities of the lumbar spine
- •Contraindications to lumbar puncture and CSF drainage (e.g., local infection at the puncture site, suspected elevated intracranial pressure, platelet count < 40,000/µL, or coagulopathy)
- •Coexisting neurological disorders that can also cause gait disturbance, such as Parkinson's disease, atypical parkinsonian syndromes, or vascular parkinsonism
- •Contraindications to MRI (e.g., presence of cardiac pacemakers, implantable defibrillators, or other non-MRI-compatible implantable medical devices)
研究组 & 干预措施
Cerebrospinal fluid drainge
Experimental
干预措施: Cerebrospinal fluid drainge (Procedure)
结局指标
主要结局
Change from Baseline in Cerebrospinal Fluid Flow Velocity (cm/s) at 30 Minutes Post-Procedure
时间窗: Baseline (Pre-intervention) and 30 minutes post-intervention
Assessment of cerebrospinal fluid flow parameters before and after the procedure.
次要结局
- Change from Baseline in 10-Meter Walk Test (10MWT) Time at 6 Hours and 24 Hours Post-Procedure(Baseline, 6 hours post-procedure, and 24 hours post-procedure)
- Change from Baseline in 10-Meter Walk Test Step Count at 6 Hours and 24 Hours Post-Procedure(Baseline, 6 hours post-procedure, and 24 hours post-procedure)
- Change from Baseline in Timed Up and Go (TUG) Test Time at 6 Hours and 24 Hours Post-Procedure(Baseline, 6 hours post-procedure, and 24 hours post-procedure)
- Change from Baseline in Cognitive Timed Up and Go (Cognitive TUG) Test Time at 6 Hours and 24 Hours Post-Procedure(Baseline, 6 hours post-procedure, and 24 hours post-procedure)
研究者
Hee Jin Chang
Professor
Chungnam National University Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium ContrastHealthy VolunteersNCT07796360National Institute of Neurological Disorders and Stroke (NINDS)15
已完成
不适用
MRI-Based Estimation of Lumbar CSF Volume and Its Clinical Impact on Spinal AnaesthesiaNCT07333703Samsun University40
尚未招募
不适用
A study assessing the spinal cord catheter placement for patients coming for csf leak repair surgeryCTRI/2025/07/091681christian medical college and hospital80
已完成
不适用
Cerebrospinal Fluid Mitochondrial Biomarkers in Ischemic Stroke and Alzheimer DiseaseNCT07600996Capital Medical University40
尚未招募
4 期
Real-time Ultrasound Guided Spinal Anaesthesia: Comparison of the Transverse Interspinous In-plane and Paramedian Saggital Oblique In-plane Injection TechniquesChiCTR1900021592香港中文大學威爾斯親王醫院麻醉與重症監護部40