Randomized Controlled Study on Non-invasive Diagnostics of Shunt Obstruction in Adult Hydrocephalus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Volumetry of CSF
研究概览
简要总结
The goal of this RCT is to test whether volumetric assessment of magnetic resonance imaging (MRI) could diagnose shunt obstruction in Adult Hydrocephalus patients, and in addition to explore correlations of blood biomarkers surrounding shunt obstruction. Thirdly to investigate correlations with clinical symptom burden before and after surgery.
The main questions it aims to answer are:
Can volumetric assessment of cerebrospinal fluid (CSF) aid in diagnosis of shunt obstruction? Are there dynamical changes in blood biomarker concentrations after shunt obstruction? How are clinical symptom burden and dynamics correlated with blood biomarker changes and volumetric changes in CSF?
After three months of shunt treatment, researchers will compare patients with "Virtual OFF" setting, to explore if simulated shunt obstruction affect measures mentioned above.
Participants randomized to the intervention group will undergo the 'Virtual OFF' setting for a period of 5-7 days, starting 3 months after initiation of shunt treatment. Symptom burden will be assessed preoperatively, at follow-up, and following the week of the shunt setting change. MRI scans will be conducted at these same time points. Participants in the control group will also meet with a nurse, but their shunt settings will remain unchanged. The control group will receive the same symptom assessments and MRI scans as the intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with normal pressure hydrocephalus (NPH)
- •Treated at either the Hydrocephalus Research Unit in Gothenburg or at the Department of Neurological Surgery at Linköping University Hospital or Sahlgrenska University Hospital
排除标准
- •Unable to conform to instructions of the study
结局指标
主要结局
Volumetry of CSF
时间窗: Preoperatively --> 3 months postop --> 3 months + 5-7 days postop
Dynamics of volumetric assessment in lateral ventricles and subarachnoid space will be analyzed in groups as a primary outcome measure.
次要结局
- Symptom burden(Preoperatively --> 3 months postop --> 3 months + 5-7 days postop)