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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03092804
Enrollment
60
Registered
2017-03-28
Start date
2016-08-01
Completion date
2019-08-31
Last updated
2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Pressure Hydrocephalus

Keywords

Shunting, Brain constructure, Neural network

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.

Interventions

A mainstream therapy for NPH. It involves the device of CSF flow control of shunts and accessories(CFDA(I)20143665605)

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
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 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

Design outcomes

Primary

MeasureTime frameDescription
The brain constructure and neural network changing one year after shuntingone year after shuntingUsing 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 day after shuntingDay 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 shuntingDay 90 after shuntingUsing the voxel based morphology technique to measure the ventricular volume and brain lobe volume •Neural network( DMN)by the resting functional MRI

Secondary

MeasureTime frameDescription
Assessment of the clinical syndrome of normal pressure hydrocephalusDay 1 after shuntingiNPHGS

Other

MeasureTime frameDescription
Cognition assessmentsDay 1 after shuntingThe neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations)
Walking ability evaluationDay 1 after shuntingIncluding 10m walking test, up and go tests

Countries

China

Contacts

Primary ContactCaiyan Liu, MD
liucy-pumch@163.com8613161202662
Backup ContactLiling Dong, MD
sophi_d@163.com8613521801162

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026