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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03092804
Other study ID # NeuroimagingNPH
Secondary ID
Status Recruiting
Phase N/A
First received March 22, 2017
Last updated March 22, 2017
Start date August 1, 2016
Est. completion date August 2019

Study information

Verified date February 2017
Source Peking Union Medical College Hospital
Contact Caiyan Liu, MD
Phone 8613161202662
Email liucy-pumch@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 2019
Est. primary completion date August 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility 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

Study Design


Intervention

Procedure:
ventriculo-peritoneal shunting
A mainstream therapy for NPH. It involves the device of CSF flow control of shunts and accessories(CFDA(I)20143665605)

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Cognition assessments The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations) Day 1 after shunting
Other Cognition assessments The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations) Day 90 after shunting
Other Cognition assessments The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations) one year after shunting
Other Walking ability evaluation Including 10m walking test, up and go tests Day 1 after shunting
Other Walking ability evaluation Including 10m walking test, up and go tests Day 90 after shunting
Other Walking ability evaluation Including 10m walking test, up and go tests one year after shunting
Primary The brain constructure and neural network changing one day 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
Day 1 after shunting
Primary The brain constructure and neural network changing 90 days 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
Day 90 after shunting
Primary The brain constructure and neural network changing 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
one year after shunting
Secondary Assessment of the clinical syndrome of normal pressure hydrocephalus iNPHGS Day 1 after shunting
Secondary Assessment of the clinical syndrome of normal pressure hydrocephalus iNPHGS Day 90 after shunting
Secondary Assessment of the clinical syndrome of normal pressure hydrocephalus iNPHGS one year after shunting
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