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Trial record 6 of 24 for:    Recruiting, Not yet recruiting, Available Studies | "Hydrocephalus"

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):

Study Description
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.

Condition or disease Intervention/treatment
Normal Pressure Hydrocephalus Procedure: ventriculo-peritoneal shunting

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Brain Structure and Neural Network Changing the Before and After Ventriculo-peritoneal Shunting in the Normal Pressure Hydrocephalus Patients
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. 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

  2. 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


  3. 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 Outcome Measures :
  1. Assessment of the clinical syndrome of normal pressure hydrocephalus [ Time Frame: Day 1 after shunting ]
    iNPHGS

  2. Assessment of the clinical syndrome of normal pressure hydrocephalus [ Time Frame: Day 90 after shunting ]
    iNPHGS

  3. Assessment of the clinical syndrome of normal pressure hydrocephalus [ Time Frame: one year after shunting ]
    iNPHGS


Other Outcome Measures:
  1. Cognition assessments [ Time Frame: Day 1 after shunting ]
    The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations)

  2. Cognition assessments [ Time Frame: Day 90 after shunting ]
    The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations)

  3. Cognition assessments [ Time Frame: one year after shunting ]
    The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations)

  4. Walking ability evaluation [ Time Frame: Day 1 after shunting ]
    Including 10m walking test, up and go tests

  5. Walking ability evaluation [ Time Frame: Day 90 after shunting ]
    Including 10m walking test, up and go tests

  6. Walking ability evaluation [ Time Frame: one year after shunting ]
    Including 10m walking test, up and go tests


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092804


Contacts
Contact: Caiyan Liu, MD 8613161202662 liucy-pumch@163.com
Contact: Liling Dong, MD 8613521801162 sophi_d@163.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Caiyan Liu, MD    8613161202662    liucy-pumch@163.com   
Contact: Liling Dong, MD    8613521801162    sophi_d@163.com   
Principal Investigator: Jing Gao, MD         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Jing Gao, MD Department of Neurology, Peking Union Medical College Hospital
More Information

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03092804     History of Changes
Other Study ID Numbers: NeuroimagingNPH
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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

Keywords provided by Peking Union Medical College Hospital:
Shunting
Brain constructure
Neural network

Additional relevant MeSH terms:
Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases