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

Not Applicable

• Conditions: Idiopathic Normal Pressure Hydrocephalus

• Registration Number: NCT04998175
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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

Detailed Description

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:

1. The cerebrospinal fluid proteomic analysis of iNPH patients before and after VP shunt surgery.

2. The structral and functional MRI analysis of iNPH patients

3. The clinical assessment of MMSE, gait scores, Kiefer score, and mRS. Objective- To study the prognostic factors of VP shunt for iNPH.

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-15
• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-08-01
• Last Update Submitted: 2021-08-01
• Study First Posted: 2021-08-10
• Last Update Posted: 2021-08-10
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proteomic pattern of CSF in iNPH patients	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in the resting state fMRI	Before surgery	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.
White matter abnormity	Beore surgery	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.
Kiefer score	Change from Baseline at 6 months after VP shunt	A score for iNPH severity; range 0-26; higher indicates higher severity.
modified Rankin scale	Change from Baseline at 6 months after VP shunt	A score for functional neurological status ; range 0-5; higher indicates higher severity.
Mini mental state Examination	Change from Baseline at 6 months after VP shunt	A score for cognitive ability; range 0-30; higher indicates higher severity.
Gait evaluation	Change from Baseline at 6 months after VP shunt	10 meters walking test were evaluated of iNPH patients.
Gray Matter Density	Before surgery	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.

Trial Locations

Locations (1)

The second affliated hospital of zhejiang university; 🇨🇳 Hangzhou, Zhejiang, China