The Role of the Glymphatic System Avaluated Thourgh mr Imaging in the Diagnosis and Management of NPH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Comparison between study and control group
研究概览
简要总结
The goal of this observational study is to evaluate the role of DTI-ALPS in the diagnostic and therapeutic management of NPH
The main questions it aims to answer are:
- Whether the glymphatic system (GS) is actually impaired in NPH
- Whether DTI-ALPS index can predict the positive response to tap test (TT) and to ventriculo-peritoneal shunt (VPS) surgery.
A healthy control group of patients (HC group) matched for age with the study group, will undergo MR with DTI-ALPS study
详细描述
Enrolled patients followed a diagnostic-therapeutic pathway, consisting of the following steps:
- t0: MR with DTI-ALPS study;
- t1 (within 7 days from T0): clinical and neurosurgical assessment with NPH-specific rating scales (detailed below) before and after a lumbar TT, including measurements of opening pressure, drainage of 40-50 mL of CSF and collection of samples for neurodegenerative biomarkers (β-Amyloid 40, 42 total and P-Tau) quantification. An MR with DTI-ALPS study within 6 hours from TT;
- t2 (within 3 months from T1): patients with a positive TT response (included responders, IR group) underwent VPS surgery, with CSF samples collected for the same neurodegenerative biomarkers (β-Amyloid 40, 42 total and P-Tau);
- t3 (three months after surgery, IR group only): clinical and neurosurgical evaluation using NPH-specific rating scales to classify patients as improved, unchanged, or worsened compared to their preoperative condition; MR with DTI-ALPS study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Suspected NPH patients according to the following:
- •Inclusion Criteria:
- •clinical and radiological diagnosis of probable NPH according to existing guidelines
- •age of over 50 years
排除标准
- •inability to undergo MR
- •diagnosis of any other neurological pathology, particularly neurodegenerative or neuroinflammatory
- •previous neurosurgical interventions on the brain of any type.
- •inability to undergo general anaesthesia
研究组 & 干预措施
Study group
Patients attending the NPH outpatient clinic were prospectively enrolled in the study. The inclusion criteria were: (i) clinical and radiological diagnosis of probable NPH according to existing guidelines and (ii) age of over 50 years. Exclusion criteria were: (i) inability to undergo MR; (ii) a diagnosis of any other neurological pathology, particularly neurodegenerative or neuroinflammatory; (iii) previous neurosurgical interventions on the brain of any type; (iv) inability to undergo general anaesthesia.
Control group
A healthy control group of patients (HC group) matched for age with the IR group, underwent MR with DTI-ALPS study. Exclusion criteria for this group were: (i) a previous diagnosis of any neurological disorder of any type. (ii) a history of neurosurgical intervention of any kind; and (iii) a prior diagnosis of malignancy of any type.
结局指标
主要结局
Comparison between study and control group
时间窗: 4 years
Difference in DTI ALPS index between NPH patients and healthy controls
次要结局
- Difference in response to tap test between NPH patients who responded and those who did not(4 years)
- Change in DTI ALPS index across treatment in NPH patients(4 years)
- Change in CSF degenerative biomarker concentrations(4 years)