Multi-omics Research of Idopathic Normal Pressure Hydrocephalus (iNPH)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ventriculo-peritoneal shunt.
- Who it may be relevant to
- Registry conditions: Idiopathic Normal Pressure Hydrocephalus. Basic parameters: 60 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multi-omics Research of Prognostic Factors of Ventriculoperitoneal Shunt for Idopathic Normal Pressure Hydrocephalus
Overview
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
- Procedure ventriculo-peritoneal shunt
A ventriculoperitoneal shunt is a tube that drains excess cerebrospinal fluid into abdomen
Primary outcome measures
- Proteomic pattern of CSF in iNPH patients [Time frame: Before surgery in lumbar CSF]
- Proteomic pattern changes of CSF in iNPH patients after VP shunt [Time frame: Change from Baseline (ventricular CSF) at 6 months after VP shunt]
Secondary outcome measures (7)
- Gray Matter Density [Time frame: Before surgery]
- Change in the resting state fMRI [Time frame: Before surgery]
- White matter abnormity [Time frame: Beore surgery]
- Kiefer score [Time frame: Change from Baseline at 6 months after VP shunt]
- Mini mental state Examination [Time frame: Change from Baseline at 6 months after VP shunt]
- Gait evaluation [Time frame: Change from Baseline at 6 months after VP shunt]
- modified Rankin scale [Time frame: Change from Baseline at 6 months after VP shunt]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The second affliated hospital of zhejiang university — Hangzhou
Identifiers
NCT: NCT04998175 · 2020-796