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

Normal Pressure Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03092804
• Other study ID #: NeuroimagingNPH
• 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
• 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

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Normal Pressure Hydrocephalus

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