Multi-omics Research of Prognostic Factors of Ventriculoperitoneal Shunt for Idopathic Normal Pressure Hydrocephalus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proteomic pattern of CSF in iNPH patients
研究概览
简要总结
The research is designed to study the prognostic factors of ventriculoperitoneal (VP) shunt for iNPH by multi-omics research
详细描述
Preoperative T1-MRI, functional MRI and diffusion MRI imaging data of iNPH patients were collected. The clinical assessment was performed before/after the lumbar puncture test and 6 months after VP shunt. Clinical assessment included Mini-mental State Examination (MMSE), gait scores, Kiefer score, and Modified Rankin Scale (mRS). The cerebrospinal fluid was collected by tap-test, and 6 months after surgery by puncturing in the VP device pump.
Methods- The primary methods used are:
- The cerebrospinal fluid proteomic analysis of iNPH patients before and after VP shunt surgery.
- The structral and functional MRI analysis of iNPH patients
- The clinical assessment of MMSE, gait scores, Kiefer score, and mRS. Objective- To study the prognostic factors of VP shunt for iNPH.
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
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years;
- •Diagnosis of iNPH based on clinical assessment
- •Participant is able to give written informed consent
排除标准
- •Combining AD and Parkinson's disease and other nervous system diseases
- •Participant is not medically available for shunt surgery
- •Secondary NPH
研究组 & 干预措施
iNPH cohort
The patients diagnosed of iNPH.
干预措施: ventriculo-peritoneal shunt (Procedure)
结局指标
主要结局
Proteomic pattern of CSF in iNPH patients
时间窗: Before surgery in lumbar CSF
Comparing the proteomic pattern differences in CSF between iNPH patients and normal age-matched normal volunteers by the analysis of mass spectrometry. Also, the responsive and non-responsive iNPH patients proteomic pattern were analzed.
Proteomic pattern changes of CSF in iNPH patients after VP shunt
时间窗: Change from Baseline (ventricular CSF) at 6 months after VP shunt
Comparing the proteomic pattern differences in CSF of iNPH patients before surgery and after VP shunt by the analysis of mass spectrometry. Also, the responsive and non-responsive iNPH patients proteomic pattern were analzed.
次要结局
- Change in the resting state fMRI(Before surgery)
- White matter abnormity(Beore surgery)
- Kiefer score(Change from Baseline at 6 months after VP shunt)
- modified Rankin scale(Change from Baseline at 6 months after VP shunt)
- Mini mental state Examination(Change from Baseline at 6 months after VP shunt)
- Gait evaluation(Change from Baseline at 6 months after VP shunt)
- Gray Matter Density(Before surgery)