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

NCT ID: NCT03092804

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-01

Study Completion Date

2019-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Normal Pressure Hydrocephalus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

ventriculo-peritoneal shunting

Intervention Type PROCEDURE

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

normal control

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

No interventions assigned to this group

Interventions

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ventriculo-peritoneal shunting

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jing Gao, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Caiyan Liu, MD

Role: CONTACT

8613161202662

Liling Dong, MD

Role: CONTACT

8613521801162

Facility Contacts

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Caiyan Liu, MD

Role: primary

8613161202662

Liling Dong, MD

Role: backup

8613521801162

Other Identifiers

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NeuroimagingNPH

Identifier Type: -

Identifier Source: org_study_id

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