Multi-omics Research of Idopathic Normal Pressure Hydrocephalus (iNPH)

Study Overview
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Brief Summary
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The research is designed to study the prognostic factors of ventriculoperitoneal (VP) shunt for iNPH by multi-omics research

Detailed Description
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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.

Official Title
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Multi-omics Research of Prognostic Factors of Ventriculoperitoneal Shunt for Idopathic Normal Pressure Hydrocephalus

Conditions
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Idiopathic Normal Pressure Hydrocephalus

Intervention / Treatment
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* Procedure: ventriculo-peritoneal shunt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 60 years; Diagnosis of iNPH based on clinical assessment Participant is able to give written informed consent Exclusion Criteria: Combining AD and Parkinson's disease and other nervous system diseases Participant is not medically available for shunt surgery Secondary NPH

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iNPH cohort<br>The patients diagnosed of iNPH. | Procedure: ventriculo-peritoneal shunt<br>* A ventriculoperitoneal shunt is a tube that drains excess cerebrospinal fluid into abdomen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteomic pattern of CSF in iNPH patients | 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. | Before surgery in lumbar CSF | 
| Proteomic pattern changes of CSF in iNPH patients 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. | Change from Baseline (ventricular CSF) at 6 months after VP shunt | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gray Matter Density | Using automatic cortical and subcortical segmentation from the 3-dimensional T1weighted images to measure gray matter density in iNPH patients before surgery compared with healthy individual group. Also, the responsive and non-responsive iNPH patients structral MRI were analzed. | Before surgery | 
| Change in the resting state fMRI | Change of BOLD singal intensity in the resting state fMRI in iNPH patients compared with normal healthy group. Also, the responsive and non-responsive iNPH patients functional MRI were analzed. | Before surgery | 
| White matter abnormity | Franctional anisotropy, mean diffusivity and apparent diffusion coefficient were measured by diffusion MRI in region of interest of iNPH patients compared with normal healthy group. Also, the responsive and non-responsive iNPH patients diffusion MRI were analzed. | Beore surgery | 
| Kiefer score | A score for iNPH severity; range 0-26; higher indicates higher severity. | Change from Baseline at 6 months after VP shunt | 
| Mini mental state Examination | A score for cognitive ability; range 0-30; higher indicates higher severity. | Change from Baseline at 6 months after VP shunt | 
| Gait evaluation | 10 meters walking test were evaluated of iNPH patients. | Change from Baseline at 6 months after VP shunt | 
| modified Rankin scale | A score for functional neurological status ; range 0-5; higher indicates higher severity. | Change from Baseline at 6 months after VP shunt | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Normal Pressure Hydrocephalus, Prognostic factor, Ventriculoperitoneal shunt, Cerebrospinal fluid, Proteomics