Multi-omics Research of Prognostic Factors of Ventriculoperitoneal Shunt for Idopathic Normal Pressure Hydrocephalus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Proteomic pattern of CSF in iNPH patients
Study Overview
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:
- 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
iNPH cohort
The patients diagnosed of iNPH.
Intervention: ventriculo-peritoneal shunt (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in the resting state fMRI(Before surgery)
- White matter abnormity(Beore surgery)
- Kiefer score(Change from Baseline at 6 months after VP shunt)
- modified Rankin scale(Change from Baseline at 6 months after VP shunt)
- Mini mental state Examination(Change from Baseline at 6 months after VP shunt)
- Gait evaluation(Change from Baseline at 6 months after VP shunt)
- Gray Matter Density(Before surgery)