Multi-omics Research of Idopathic Normal Pressure Hydrocephalus (iNPH)

Idiopathic Normal Pressure Hydrocephalus Clinical Trial

Official title:

Multi-omics Research of Prognostic Factors of Ventriculoperitoneal Shunt for Idopathic Normal Pressure Hydrocephalus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04998175
• Other study ID #: 2020-796
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Junming Zhu, M.D.
• Phone: 86-13968055768
• Email: dr.zhujunming[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research is designed to study the prognostic factors of ventriculoperitoneal (VP) shunt for iNPH by multi-omics research

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Idiopathic Normal Pressure Hydrocephalus

Intervention

Procedure:
• ventriculo-peritoneal shunt
A ventriculoperitoneal shunt is a tube that drains excess cerebrospinal fluid into abdomen

Locations

Country	Name	City	State
China	The second affliated hospital of zhejiang university	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Westlake University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteomic pattern of CSF in iNPH patients	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.	Before surgery in lumbar CSF
Primary	Proteomic pattern changes of CSF in iNPH patients 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.	Change from Baseline (ventricular CSF) at 6 months after VP shunt
Secondary	Gray Matter Density	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.	Before surgery
Secondary	Change in the resting state fMRI	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.	Before surgery
Secondary	White matter abnormity	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.	Beore surgery
Secondary	Kiefer score	A score for iNPH severity; range 0-26; higher indicates higher severity.	Change from Baseline at 6 months after VP shunt
Secondary	Mini mental state Examination	A score for cognitive ability; range 0-30; higher indicates higher severity.	Change from Baseline at 6 months after VP shunt
Secondary	Gait evaluation	10 meters walking test were evaluated of iNPH patients.	Change from Baseline at 6 months after VP shunt
Secondary	modified Rankin scale	A score for functional neurological status ; range 0-5; higher indicates higher severity.	Change from Baseline at 6 months after VP shunt