NCT04998175

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Sep 2020Dec 2026

Study Start

First participant enrolled

September 15, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

6.3 years

First QC Date

June 21, 2021

Last Update Submit

April 21, 2026

Conditions

Idiopathic Normal Pressure Hydrocephalus

Keywords

Idiopathic Normal Pressure HydrocephalusPrognostic factorVentriculoperitoneal shuntCerebrospinal fluidProteomics

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Gray Matter Density

    Before surgery

  • Change in the resting state fMRI

    Before surgery

  • White matter abnormity

    Beore surgery

  • Kiefer score

    Change from Baseline at 6 months after VP shunt

  • Mini mental state Examination

    Change from Baseline at 6 months after VP shunt

  • +2 more secondary outcomes

Study Arms (1)

iNPH cohort

EXPERIMENTAL

The patients diagnosed of iNPH.

Procedure: ventriculo-peritoneal shunt

Interventions

ventriculo-peritoneal shuntPROCEDURE

A ventriculoperitoneal shunt is a tube that drains excess cerebrospinal fluid into abdomen

iNPH cohort

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 60 years;
  • Diagnosis of iNPH based on clinical assessment
  • Participant is able to give written informed consent

You may not qualify if:

  • Combining AD and Parkinson's disease and other nervous system diseases
  • Participant is not medically available for shunt surgery
  • Secondary NPH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affliated hospital of zhejiang university

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Interventions

Ventriculoperitoneal Shunt

Intervention Hierarchy (Ancestors)

Cerebrospinal Fluid ShuntsAnastomosis, SurgicalSurgical Procedures, OperativeNeurosurgical Procedures

Study Officials

  • Zhoule Zhu

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junming Zhu, M.D.

CONTACT

86-13968055768dr.zhujunming@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2021

First Posted

August 10, 2021

Study Start

September 15, 2020

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

CN(1)