Multi-omics analysis of iNPH and ventriculoperitoneal shunt outcomes
Official title: Multi-omics Research of Prognostic Factors of Ventriculoperitoneal Shunt for Idopathic Normal Pressure Hydrocephalus
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT04998175 · Data updated 2026-11-12
This project will test whether changes in cerebrospinal fluid proteins and brain MRI before and after a ventriculoperitoneal shunt can help predict recovery for people aged 60 and older with idiopathic normal pressure hydrocephalus.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 60 Years to 90 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | September 15, 2020 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | April 24, 2026 |
| Trial ID | NCT04998175 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People aged 60 or older with a clinical diagnosis of idiopathic normal pressure hydrocephalus who can give informed consent and are medically eligible for VP shunt surgery.
✕Probably not a fit
Patients with secondary NPH, concurrent Alzheimer’s or Parkinson’s disease, or those who are not medically fit for shunt surgery are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants undergo preoperative T1-weighted, functional, and diffusion MRI and clinical assessments including MMSE, gait scores, Kiefer score, and modified Rankin Scale before and after a lumbar tap test and again six months after VP shunt surgery. Cerebrospinal fluid is collected at the tap test and from the VP device pump six months post‑surgery for proteomic analysis. The study combines CSF proteomics with structural and functional MRI analyses to identify biological and imaging prognostic factors linked to shunt response. Data are collected at The Second Affiliated Hospital, School of Medicine, Zhejiang University with Westlake University collaboration.
Why it matters
Potential benefit: If successful, the work could help doctors predict who is most likely to improve after VP shunt and guide surgical decisions.
How similar studies have gone: Prior small studies have linked CSF biomarkers and specific MRI features to shunt response, but comprehensive multi-omics prognostic models for iNPH remain limited and relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
The second affliated hospital of zhejiang university
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Zhoule Zhu — Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study coordinator: Junming Zhu, M.D.
- Email: dr.zhujunming@zju.edu.cn
- Phone: 86-13968055768
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.