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NCT Number: NCT04998175

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

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

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Key information

Conditions

Idiopathic Normal Pressure Hydrocephalus

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The second affliated hospital of zhejiang university

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Junming Zhu, M.D

CONTACT

[email protected]

86-13968055768

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ventriculo-peritoneal shunt

Procedure

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

Primary outcomes

  1. Proteomic pattern of CSF in iNPH patients

    Time frame: 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.

  2. Proteomic pattern changes of CSF in iNPH patients after VP shunt

    Time frame: 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 outcomes

  1. Gray Matter Density

    Time frame: 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.

  2. Change in the resting state fMRI

    Time frame: 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.

  3. White matter abnormity

    Time frame: 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.

  4. Kiefer score

    Time frame: Change from Baseline at 6 months after VP shunt

    A score for iNPH severity; range 0-26; higher indicates higher severity.

  5. Mini mental state Examination

    Time frame: Change from Baseline at 6 months after VP shunt

    A score for cognitive ability; range 0-30; higher indicates higher severity.

  6. Gait evaluation

    Time frame: Change from Baseline at 6 months after VP shunt

    10 meters walking test were evaluated of iNPH patients.

  7. modified Rankin scale

    Time frame: Change from Baseline at 6 months after VP shunt

    A score for functional neurological status ; range 0-5; higher indicates higher severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Junming Zhu, M.D.

CONTACT

[email protected]

86-13968055768

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Westlake University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2021
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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