Clinical trial NCT04998175: Multi-omics Research of Idopathic Normal Pressure Hydrocephalus (iNPH)
Official title: Multi-omics Research of Prognostic Factors of Ventriculoperitoneal Shunt for Idopathic Normal Pressure Hydrocephalus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Normal Pressure Hydrocephalus
Keywords: Idiopathic Normal Pressure Hydrocephalus
Prognostic factor
Ventriculoperitoneal shunt
Cerebrospinal fluid
Proteomics
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Westlake University
First posted: 2021-08-10
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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:

1. The cerebrospinal fluid proteomic analysis of iNPH patients before and after VP shunt surgery.
2. The structral and functional MRI analysis of iNPH patients
3. The clinical assessment of MMSE, gait scores, Kiefer score, and mRS. Objective- To study the prognostic factors of VP shunt for iNPH.

Eligibility 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

Primary outcomes:
measure: Proteomic pattern of CSF in iNPH patients
timeFrame: Before surgery in lumbar CSF
measure: Proteomic pattern changes of CSF in iNPH patients after VP shunt
timeFrame: Change from Baseline (ventricular CSF) at 6 months after VP shunt
Secondary outcomes:
measure: Gray Matter Density
timeFrame: Before surgery
measure: Change in the resting state fMRI
timeFrame: Before surgery
measure: White matter abnormity
timeFrame: Beore surgery
measure: Kiefer score
timeFrame: Change from Baseline at 6 months after VP shunt
measure: Mini mental state Examination
timeFrame: Change from Baseline at 6 months after VP shunt
measure: Gait evaluation
timeFrame: Change from Baseline at 6 months after VP shunt
measure: modified Rankin scale
timeFrame: Change from Baseline at 6 months after VP shunt
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affliated hospital of zhejiang university
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Zhoule Zhu
role: PRINCIPAL_INVESTIGATOR
References: