Idiopathic Normal Pressure Hydrocephalus
Conditions
Keywords
Idiopathic Normal Pressure Hydrocephalus, Prognostic factor, Ventriculoperitoneal shunt, Cerebrospinal fluid, Proteomics
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.
Interventions
PROCEDUREventriculo-peritoneal shunt
A ventriculoperitoneal shunt is a tube that drains excess cerebrospinal fluid into abdomen
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Westlake University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proteomic pattern of CSF in iNPH patients | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Gray Matter Density | 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. |
| Change in the resting state fMRI | 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. |
| White matter abnormity | 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. |
| Kiefer score | Change from Baseline at 6 months after VP shunt | A score for iNPH severity; range 0-26; higher indicates higher severity. |
| Mini mental state Examination | Change from Baseline at 6 months after VP shunt | A score for cognitive ability; range 0-30; higher indicates higher severity. |
| Gait evaluation | Change from Baseline at 6 months after VP shunt | 10 meters walking test were evaluated of iNPH patients. |
| modified Rankin scale | Change from Baseline at 6 months after VP shunt | A score for functional neurological status ; range 0-5; higher indicates higher severity. |
Countries
China
Contacts
CONTACTJunming Zhu, M.D.
PRINCIPAL_INVESTIGATORZhoule Zhu
Second Affiliated Hospital, School of Medicine, Zhejiang University
Outcome results
None listed