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Clinical Trials/NCT03092804
NCT03092804UnknownNot Applicable

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

Peking Union Medical College Hospital1 site in 1 country60 target enrollmentStarted: August 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
The brain constructure and neural network changing one day after shunting

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
50 Years to 80 Years (Adult, Older Adult)
Sex
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.
  • Are 50 years old or older
  • Patients who understand the study protocol
  • Patients who meet the criteria for NPH
  • A typical personal history
  • A typical brain imaging on head CT or MRI
  • Normal LP findings excluding other conditions
  • Exclusion of other conditions causing the symptomatology

Exclusion Criteria

  • Patients below the age of 50 years.
  • Patients who underwent shunt surgery before

Outcomes

Primary Outcomes

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 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

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

Secondary Outcomes

  • Assessment of the clinical syndrome of normal pressure hydrocephalus(one year after shunting)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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