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

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2018

Interventions

  • Procedure: ventriculo-peritoneal shunting
    • A mainstream therapy for NPH. It involves the device of CSF flow control of shunts and accessories(CFDA(I)20143665605)

Arms, Groups and Cohorts

  • 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.
  • normal control
    • Healthy volunteers will undergo the examination of brain constructure and functional MRI.

Clinical Trial Outcome Measures

Primary Measures

  • The brain constructure and neural network changing one day after shunting
    • Time Frame: 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
    • Time Frame: 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
  • The brain constructure and neural network changing one year after shunting
    • Time Frame: 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

Secondary Measures

  • Assessment of the clinical syndrome of normal pressure hydrocephalus
    • Time Frame: Day 1 after shunting
    • iNPHGS
  • Assessment of the clinical syndrome of normal pressure hydrocephalus
    • Time Frame: Day 90 after shunting
    • iNPHGS
  • Assessment of the clinical syndrome of normal pressure hydrocephalus
    • Time Frame: one year after shunting
    • iNPHGS

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Peking Union Medical College Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jing Gao, MD, Principal Investigator, Department of Neurology, Peking Union Medical College Hospital
  • Overall Contact(s)
    • Caiyan Liu, MD, 8613161202662, liucy-pumch@163.com

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