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

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ClinicalTrials.gov Identifier: NCT03092804
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

March 22, 2017
March 28, 2017
March 28, 2017
August 1, 2016
August 2018   (Final data collection date for primary outcome measure)
  • 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

Same as current
No Changes Posted
  • 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
Same as current
  • Cognition assessments [ Time Frame: Day 1 after shunting ]
    The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations)
  • Cognition assessments [ Time Frame: Day 90 after shunting ]
    The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations)
  • Cognition assessments [ Time Frame: one year after shunting ]
    The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations)
  • Walking ability evaluation [ Time Frame: Day 1 after shunting ]
    Including 10m walking test, up and go tests
  • Walking ability evaluation [ Time Frame: Day 90 after shunting ]
    Including 10m walking test, up and go tests
  • Walking ability evaluation [ Time Frame: one year after shunting ]
    Including 10m walking test, up and go tests
Same as current
 
The Brain Structure and Neural Network Changing the Before and After Ventriculo-peritoneal Shunting in the Normal Pressure Hydrocephalus Patients
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Normal Pressure Hydrocephalus
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 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.

    Intervention: Procedure: ventriculo-peritoneal shunting
  • normal control
    Healthy volunteers will undergo the examination of brain constructure and functional MRI.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Same as current
August 2019
August 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 80 Years   (Adult, Senior)
Yes
Contact: Caiyan Liu, MD 8613161202662 liucy-pumch@163.com
Contact: Liling Dong, MD 8613521801162 sophi_d@163.com
China
 
 
NCT03092804
NeuroimagingNPH
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Plan to Share IPD: No
Peking Union Medical College Hospital
Peking Union Medical College Hospital
Not Provided
Principal Investigator: Jing Gao, MD Department of Neurology, Peking Union Medical College Hospital
Peking Union Medical College Hospital
February 2017