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

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.

Study Overview

• Status: Unknown
• Conditions: Normal Pressure Hydrocephalus
• Intervention / Treatment: Procedure: ventriculo-peritoneal shunting

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Caiyan Liu, MD; Phone Number: 8613161202662; Email: liucy-pumch@163.com
      • Contact: Liling Dong, MD; Phone Number: 8613521801162; Email: sophi_d@163.com
      • Principal Investigator: Jing Gao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with physical and cognitive symptoms and brain image findings (Brain CT or MRI) suggestive of NPH were evaluated at neurological outpatient clinic of Peking Union Medical College Hospital according to the NPH diagnosis criteria.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normal pressure hydrocephalus; 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.	Procedure: ventriculo-peritoneal shunting; A mainstream therapy for NPH. It involves the device of CSF flow control of shunts and accessories(CFDA(I)20143665605)
normal control; Healthy volunteers will undergo the examination of brain constructure and functional MRI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The brain constructure and neural network changing one day 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	Day 1 after shunting
The brain constructure and neural network changing 90 days 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	Day 90 after shunting
The brain constructure and neural network changing 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	one year after shunting

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the clinical syndrome of normal pressure hydrocephalus	iNPHGS	Day 1 after shunting
Assessment of the clinical syndrome of normal pressure hydrocephalus	iNPHGS	Day 90 after shunting
Assessment of the clinical syndrome of normal pressure hydrocephalus	iNPHGS	one year after shunting

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognition assessments	The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations)	Day 1 after shunting
Cognition assessments	The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations)	Day 90 after shunting
Cognition assessments	The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations)	one year after shunting
Walking ability evaluation	Including 10m walking test, up and go tests	Day 1 after shunting
Walking ability evaluation	Including 10m walking test, up and go tests	Day 90 after shunting
Walking ability evaluation	Including 10m walking test, up and go tests	one year after shunting

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Jing Gao, MD, Department of Neurology, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Shunting; Brain constructure; Neural network
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus; Hydrocephalus, Normal Pressure
• Other Study ID Numbers: NeuroimagingNPH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes