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

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

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

Study Overview

• Status: Unknown
• Conditions: Idiopathic Normal Pressure Hydrocephalus
• Intervention / Treatment: Procedure: ventriculo-peritoneal shunt

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junming Zhu, M.D.; Phone Number: 86-13968055768; Email: dr.zhujunming@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The second affliated hospital of zhejiang university
      • Contact: Junming Zhu, M.D; Phone Number: 86-13968055768; Email: dr.zhujunming@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: iNPH cohort; The patients diagnosed of iNPH.	Procedure: ventriculo-peritoneal shunt; A ventriculoperitoneal shunt is a tube that drains excess cerebrospinal fluid into abdomen

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Westlake University
• Investigators: Principal Investigator: Zhoule Zhu, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2020
• Primary Completion (ANTICIPATED): December 30, 2022
• Study Completion (ANTICIPATED): December 30, 2022

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: August 1, 2021
• First Posted (ACTUAL): August 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 1, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Proteomics; Cerebrospinal fluid; Ventriculoperitoneal shunt; Idiopathic Normal Pressure Hydrocephalus; Prognostic factor
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus; Hydrocephalus, Normal Pressure
• Other Study ID Numbers: 2020-796

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No