Clinical trial NCT03092804: The Brain Structure and Neural Network Changing the Before and After Ventriculo-peritoneal Shunting in the Normal Pressure Hydrocephalus Patients
Official title: The Brain Structure and Neural Network Changing the Before and After Ventriculo-peritoneal Shunting in the Normal Pressure Hydrocephalus Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Normal Pressure Hydrocephalus
Keywords: Shunting
Brain constructure
Neural network
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The brain constructure and neural network changing one day after shunting
timeFrame: Day 1 after shunting
measure: The brain constructure and neural network changing 90 days after shunting
timeFrame: Day 90 after shunting
measure: The brain constructure and neural network changing one year after shunting
timeFrame: one year after shunting
Secondary outcomes:
measure: Assessment of the clinical syndrome of normal pressure hydrocephalus
timeFrame: Day 1 after shunting
measure: Assessment of the clinical syndrome of normal pressure hydrocephalus
timeFrame: Day 90 after shunting
measure: Assessment of the clinical syndrome of normal pressure hydrocephalus
timeFrame: one year after shunting
Other outcomes:
measure: Cognition assessments
timeFrame: Day 1 after shunting
measure: Cognition assessments
timeFrame: Day 90 after shunting
measure: Cognition assessments
timeFrame: one year after shunting
measure: Walking ability evaluation
timeFrame: Day 1 after shunting
measure: Walking ability evaluation
timeFrame: Day 90 after shunting
measure: Walking ability evaluation
timeFrame: one year after shunting
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Department of Neurology, Peking Union Medical College Hospital
name: Jing Gao, MD
role: PRINCIPAL_INVESTIGATOR
References: