Multi-omics analysis of iNPH and ventriculoperitoneal shunt outcomes
Multi-omics Research of Prognostic Factors of Ventriculoperitoneal Shunt for Idopathic Normal Pressure Hydrocephalus
NA · Second Affiliated Hospital, School of Medicine, Zhejiang University · NCT04998175
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 60 Years to 90 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT04998175 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang
- The second affliated hospital of zhejiang university — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Principal investigator: Zhoule Zhu — Second Affiliated Hospital, School of Medicine, Zhejiang University
- Study coordinator: Junming Zhu, M.D.
- Email: dr.zhujunming@zju.edu.cn
- Phone: 86-13968055768
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Idiopathic Normal Pressure Hydrocephalus, Prognostic factor, Ventriculoperitoneal shunt, Cerebrospinal fluid, Proteomics