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

NCT03092804 | Unknown FDA Device

• 1 other identifier: NeuroimagingNPH
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Pressure Hydrocephalus

Keywords

Shunting; Brain constructure; Neural network

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Assessment of the clinical syndrome of normal pressure hydrocephalus

  Day 1 after shunting

• Assessment of the clinical syndrome of normal pressure hydrocephalus

  Day 90 after shunting

• Assessment of the clinical syndrome of normal pressure hydrocephalus

  one year after shunting

Other Outcomes (6)

• Cognition assessments

  Day 1 after shunting

• Cognition assessments

  Day 90 after shunting

• Cognition assessments

  one year after shunting

Study Arms (2)

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

normal control

Healthy volunteers will undergo the examination of brain constructure and functional MRI.

Interventions

ventriculo-peritoneal shunting PROCEDURE

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

normal pressure hydrocephalus

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with physical and cognitive symptoms and brain image findings (Brain CT or MRI) suggestive of NPH were evaluated at neurological outpatient clinic of Peking Union Medical College Hospital according to the NPH diagnosis criteria.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jing Gao, MD

  Department of Neurology, Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caiyan Liu, MD

CONTACT

8613161202662; liucy-pumch@163.com

Liling Dong, MD

CONTACT

8613521801162; sophi_d@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 28, 2017
• Study Start: August 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2019
• Last Updated: March 28, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)