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

Primary Purpose

Idiopathic Normal Pressure Hydrocephalus

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ventriculo-peritoneal shunt
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Normal Pressure Hydrocephalus focused on measuring Idiopathic Normal Pressure Hydrocephalus, Prognostic factor, Ventriculoperitoneal shunt, Cerebrospinal fluid, Proteomics

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The second affliated hospital of zhejiang universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

iNPH cohort

Arm Description

The patients diagnosed of iNPH.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
Kiefer score
A score for iNPH severity; range 0-26; higher indicates higher severity.
Mini mental state Examination
A score for cognitive ability; range 0-30; higher indicates higher severity.
Gait evaluation
10 meters walking test were evaluated of iNPH patients.
modified Rankin scale
A score for functional neurological status ; range 0-5; higher indicates higher severity.

Full Information

First Posted
June 21, 2021
Last Updated
August 1, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Westlake University
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1. Study Identification

Unique Protocol Identification Number
NCT04998175
Brief Title
Multi-omics Research of Idopathic Normal Pressure Hydrocephalus (iNPH)
Official Title
Multi-omics Research of Prognostic Factors of Ventriculoperitoneal Shunt for Idopathic Normal Pressure Hydrocephalus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Westlake University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Normal Pressure Hydrocephalus
Keywords
Idiopathic Normal Pressure Hydrocephalus, Prognostic factor, Ventriculoperitoneal shunt, Cerebrospinal fluid, Proteomics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iNPH cohort
Arm Type
Experimental
Arm Description
The patients diagnosed of iNPH.
Intervention Type
Procedure
Intervention Name(s)
ventriculo-peritoneal shunt
Intervention Description
A ventriculoperitoneal shunt is a tube that drains excess cerebrospinal fluid into abdomen
Primary Outcome Measure Information:
Title
Proteomic pattern of CSF in iNPH patients
Description
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.
Time Frame
Before surgery in lumbar CSF
Title
Proteomic pattern changes of CSF in iNPH patients after VP shunt
Description
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.
Time Frame
Change from Baseline (ventricular CSF) at 6 months after VP shunt
Secondary Outcome Measure Information:
Title
Gray Matter Density
Description
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.
Time Frame
Before surgery
Title
Change in the resting state fMRI
Description
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.
Time Frame
Before surgery
Title
White matter abnormity
Description
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.
Time Frame
Beore surgery
Title
Kiefer score
Description
A score for iNPH severity; range 0-26; higher indicates higher severity.
Time Frame
Change from Baseline at 6 months after VP shunt
Title
Mini mental state Examination
Description
A score for cognitive ability; range 0-30; higher indicates higher severity.
Time Frame
Change from Baseline at 6 months after VP shunt
Title
Gait evaluation
Description
10 meters walking test were evaluated of iNPH patients.
Time Frame
Change from Baseline at 6 months after VP shunt
Title
modified Rankin scale
Description
A score for functional neurological status ; range 0-5; higher indicates higher severity.
Time Frame
Change from Baseline at 6 months after VP shunt

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junming Zhu, M.D.
Phone
86-13968055768
Email
dr.zhujunming@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhoule Zhu
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The second affliated hospital of zhejiang university
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junming Zhu, M.D
Phone
86-13968055768
Email
dr.zhujunming@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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