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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03092804
Collaborator
(none)
60
1
36
1.7

Study Details

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 Phase
  • Procedure: ventriculo-peritoneal shunting

Study Design

Study Type:
Observational
Anticipated 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 :
Aug 1, 2016
Anticipated Primary Completion Date :
Aug 1, 2018
Anticipated Study Completion Date :
Aug 1, 2019

Arms and Interventions

Arm 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 [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 [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 [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 [Day 1 after shunting]

    iNPHGS

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

    iNPHGS

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

    iNPHGS

Other Outcome Measures

  1. Cognition assessments [Day 1 after shunting]

    The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations)

  2. Cognition assessments [Day 90 after shunting]

    The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations)

  3. Cognition assessments [one year after shunting]

    The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations)

  4. Walking ability evaluation [Day 1 after shunting]

    Including 10m walking test, up and go tests

  5. Walking ability evaluation [Day 90 after shunting]

    Including 10m walking test, up and go tests

  6. Walking ability evaluation [one year after shunting]

    Including 10m walking test, up and go tests

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

  4. A typical personal history

  5. A typical brain imaging on head CT or MRI

  6. Normal LP findings excluding other conditions

  7. 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

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing Beijing China 100730

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT03092804
Other Study ID Numbers:
  • NeuroimagingNPH
First Posted:
Mar 28, 2017
Last Update Posted:
Mar 28, 2017
Last Verified:
Feb 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Peking Union Medical College Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 28, 2017