Normal Pressure HydrocephalusNCT03092804
The Brain Structure and Neural Network Changing the Before and After Ventriculo-peritoneal Shunting in the Normal Pressure Hydrocephalus Patients
An observational study of Normal Pressure Hydrocephalus, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Pressure Hydrocephalus
- What is being tested?
- ventriculo-peritoneal shunting
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2016to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
- Exclusion of other conditions causing the symptomatology
Who cannot join
- Patients below the age of 50 years.
- Patients who underwent shunt surgery before
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Caiyan Liu, MD, 8613161202662, liucy-pumch@163.com
Liling Dong, MD, 8613521801162, sophi_d@163.com
About this study
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
- Being tested
- ventriculo-peritoneal shunting
- Keywords
- Shunting, Brain constructure, Neural network
- Medical subject headings
- Hydrocephalus, Normal Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventriculo-peritoneal shuntingProcedure or surgery
A mainstream therapy for NPH. It involves the device of CSF flow control of shunts and accessories(CFDA(I)20143665605)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: ventriculo-peritoneal shunting | |
| normal control | Healthy volunteers will undergo the examination of brain constructure and functional MRI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: one year after shunting
Secondary outcomes (3)
Assessment of the clinical syndrome of normal pressure hydrocephalus
iNPHGS
Measured: Day 1 after shunting
Assessment of the clinical syndrome of normal pressure hydrocephalus
iNPHGS
Measured: Day 90 after shunting
Assessment of the clinical syndrome of normal pressure hydrocephalus
iNPHGS
Measured: one year after shunting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start1 Aug 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Gao, MD, Principal investigator, Department of Neurology, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092804
- Sponsor's protocol ID
- NeuroimagingNPH
- Status last verified
- Feb 2017
- First submitted
- 22 Mar 2017
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Brain Structure and Neural Network Changing the Before and After Ventriculo-peritoneal Shunting in the Normal Pressure Hydrocephalus Patients
- ClinicalTrials.gov ID
- NCT03092804
- Acronym / sponsor ID
- NeuroimagingNPH
- Conditions
- Normal Pressure Hydrocephalus
- Keywords
- Shunting, Brain constructure, Neural network
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal pressure hydrocephalus | – | Procedure: ventriculo-peritoneal shuntingIncluded 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. |
| normal control | – | –Healthy volunteers will undergo the examination of brain constructure and functional MRI. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Patients below the age of 50 years.
- Patients who underwent shunt surgery before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ventriculo-peritoneal shuntingA mainstream therapy for NPH. It involves the device of CSF flow control of shunts and accessories(CFDA(I)20143665605) | Procedure or surgery | normal pressure hydrocephalus |
Primary outcome
The brain constructure and neural network changing one day after shunting
Time frame: Day 1 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
The brain constructure and neural network changing 90 days after shunting
Time frame: Day 90 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
The brain constructure and neural network changing one year after shunting
Time frame: 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
3 secondary outcomes
Assessment of the clinical syndrome of normal pressure hydrocephalus
Time frame: Day 1 after shunting
Assessment of the clinical syndrome of normal pressure hydrocephalus
Time frame: Day 90 after shunting
Assessment of the clinical syndrome of normal pressure hydrocephalus
Time frame: one year after shunting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Normal Pressure Hydrocephalus
Not yet recruitingObservational study
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
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Analysis of Cerebrospinal Fluid Dynamics in Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus
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Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
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Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials
NPH (Normal Pressure Hydrocephalus)
RecruitingObservational study
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Hydrocephalus, Normal Pressure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Gao, MD principal investigator
Department of Neurology, Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Pressure Hydrocephalus, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caiyan Liu, MD (8613161202662, liucy-pumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The brain constructure and neural network changing one day after shunting (time frame: Day 1 after shunting). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.