The Brain Structure and Neural Network Changing the Before and After Ventriculo-peritoneal Shunting in the Normal Pressure Hydrocephalus Patients

• Conditions: Normal Pressure Hydrocephalus
• Interventions: Procedure: ventriculo-peritoneal shunting

• Registration Number: NCT03092804
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

With the advent of the aging society, dementia becomes the focus of common people. As for the neurodegeneration dementia, no disease modifying treatments have been discovered. Idiopathic normal pressure hydrocephalus (iNPH) is considered as one of reversible dementia, which can be hint by the surgery. In addition, dementia of iNPH is the typical subcortical dementia. Therefore exploring the pathogenic mechanism is conducive to the early diagnosis and treatment. This research is to monitor the changing of iNPHGS, cognitive function, walking ability as well as brain construction imaging and neural network before and after ventriculo-peritoneal shunting in order to demonstrate the pathogenesis of triads. In the process, the supplementary test, for instance, CSF tap test, will be validated the predictive value.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-01
• Status Verified: 2017-02
• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-22
• Last Update Submitted: 2017-03-22
• Study First Posted: 2017-03-28
• Last Update Posted: 2017-03-28
• Primary Completion: 2018-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

ncluded will be subjects with a probable diagnosis of NPH. The diagnosis will be based primarily on presence of gait impairment plus at least one other impairment in urinary symptoms, cognition impairment or both.

1. Are 50 years old or older

2. Patients who understand the study protocol

3. Patients who meet the criteria for NPH

   1. A typical personal history
   2. A typical brain imaging on head CT or MRI
   3. Normal LP findings excluding other conditions
   4. Exclusion of other conditions causing the symptomatology

Exclusion Criteria

1. Patients below the age of 50 years.
2. Patients who underwent shunt surgery before

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
normal pressure hydrocephalus	ventriculo-peritoneal shunting	Included will be subjects with a probable diagnosis of NPH. The diagnosis will be based primarily on presence of gait impairment plus at least one other impairment in urinary symptoms, cognition impairment or both The NPH patients will undergo the CSF tap test and then receive the ventriculo-peritoneal shunting surgery. They will have the examination of brain constructure neuroimaging and functional MRI prior to and posterior to the shunting.

Primary Outcome Measures

Name	Time	Method
The brain constructure and neural network changing one year after shunting	one year after shunting	Using the voxel based morphology technique to measure the ventricular volume and brain lobe volume; •Neural network( DMN)by the resting functional MRI
The brain constructure and neural network changing one day after shunting	Day 1 after shunting	* Using the voxel based morphology technique to measure the ventricular volume and brain lobe volume; * Neural network( DMN)by the resting functional MRI
The brain constructure and neural network changing 90 days after shunting	Day 90 after shunting	Using the voxel based morphology technique to measure the ventricular volume and brain lobe volume; •Neural network( DMN)by the resting functional MRI

Secondary Outcome Measures

Name	Time	Method
Assessment of the clinical syndrome of normal pressure hydrocephalus	one year after shunting	iNPHGS

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China