Idiopathic Normal Pressure HydrocephalusNCT04998175
Multi-omics Research of Idopathic Normal Pressure Hydrocephalus (iNPH)
A study testing ventriculo-peritoneal shunt in people with Idiopathic Normal Pressure Hydrocephalus, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The research is designed to study the prognostic factors of ventriculoperitoneal (VP) shunt for iNPH by multi-omics research Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Idiopathic Normal Pressure Hydrocephalus
- What is being tested?
- ventriculo-peritoneal shunt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2020to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years;
- Diagnosis of iNPH based on clinical assessment
- Participant is able to give written informed consent
Who cannot join
- Combining AD and Parkinson's disease and other nervous system diseases
- Participant is not medically available for shunt surgery
- Secondary NPH
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The second affliated hospital of zhejiang university
Hangzhou, Zhejiang, 310009
Junming Zhu, M.D, 86-13968055768, dr.zhujunming@zju.edu.cn
About this study
Official title: 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
Read the 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.
- Conditions
- Idiopathic Normal Pressure Hydrocephalus
- Being tested
- ventriculo-peritoneal shunt
- Keywords
- Idiopathic Normal Pressure Hydrocephalus, Prognostic factor, Ventriculoperitoneal shunt, Cerebrospinal fluid, Proteomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventriculo-peritoneal shuntProcedure or surgery
A ventriculoperitoneal shunt is a tube that drains excess cerebrospinal fluid into abdomen
| Study group | Role | What they receive |
|---|---|---|
| iNPH cohort | Experimental | The patients diagnosed of iNPH. Receives: Procedure: ventriculo-peritoneal shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from Baseline (ventricular CSF) at 6 months after VP shunt
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: Beore surgery
Kiefer score
A score for iNPH severity; range 0-26; higher indicates higher severity.
Measured: 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.
Measured: Change from Baseline at 6 months after VP shunt
Gait evaluation
10 meters walking test were evaluated of iNPH patients.
Measured: 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.
Measured: Change from Baseline at 6 months after VP shunt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start15 Sep 2020
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Westlake University
- Responsible party
- Sponsor
- Investigators
- Zhoule Zhu, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998175
- Sponsor's protocol ID
- 2020-796
- Status last verified
- Apr 2026
- First submitted
- 21 Jun 2021
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics Research of Prognostic Factors of Ventriculoperitoneal Shunt for Idopathic Normal Pressure Hydrocephalus
- ClinicalTrials.gov ID
- NCT04998175
- Acronym / sponsor ID
- 2020-796
- Conditions
- Idiopathic Normal Pressure Hydrocephalus
- Keywords
- Idiopathic Normal Pressure Hydrocephalus, Prognostic factor, Ventriculoperitoneal shunt, Cerebrospinal fluid, Proteomics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Westlake University
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iNPH cohort | Experimental | Procedure: ventriculo-peritoneal shuntThe patients diagnosed of iNPH. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 60 years;
- Diagnosis of iNPH based on clinical assessment
- Participant is able to give written informed consent
Key exclusion criteria (3 listed)
- Combining AD and Parkinson's disease and other nervous system diseases
- Participant is not medically available for shunt surgery
- Secondary NPH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ventriculo-peritoneal shuntA ventriculoperitoneal shunt is a tube that drains excess cerebrospinal fluid into abdomen | Procedure or surgery | iNPH cohort |
Primary outcome
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.
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.
7 secondary outcomes
Gray Matter Density
Time frame: Before surgery
Change in the resting state fMRI
Time frame: Before surgery
White matter abnormity
Time frame: Beore surgery
Kiefer score
Time frame: Change from Baseline at 6 months after VP shunt
Mini mental state Examination
Time frame: Change from Baseline at 6 months after VP shunt
Gait evaluation
Time frame: Change from Baseline at 6 months after VP shunt
modified Rankin scale
Time frame: Change from Baseline at 6 months after VP shunt
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhoule Zhu principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventriculo-peritoneal shunt in people with Idiopathic Normal Pressure Hydrocephalus, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junming Zhu, M.D. (86-13968055768, dr.zhujunming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomic pattern of CSF in iNPH patients (time frame: Before surgery in lumbar CSF). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.