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Recruitment status
Unique ID issued by UMIN UMIN000002374
Receipt No. R000002916
Scientific Title Japan Shunt Registry of Idiopathic Normal Pressure Hydrocephalus
Date of disclosure of the study information 2009/09/01
Last modified on 2009/08/24

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Basic information
Public title Japan Shunt Registry of Idiopathic Normal Pressure Hydrocephalus
Acronym JSR
Scientific Title Japan Shunt Registry of Idiopathic Normal Pressure Hydrocephalus
Scientific Title:Acronym JSR
Region
Japan

Condition
Condition Idiopathic Normal Pressure Hydrocephalus
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy and Safty of verious treatments for Idiopathic Normal Pressure Hydrocephalus
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes iNPH grading scale
Key secondary outcomes Modified Rankin Scale
Timed back & forth gait test
Mini-Mental State Examination
Care-giver's burden

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
60 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. More than one of NPH triad
2. Ventriculomegaly
Key exclusion criteria Obstacles for six months follow-up
Secondary NPH
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Arai
Organization Juntendo University
Division name Neurosurgery
Zip code
Address Hongo 2-1-1, Bunkyou-ku, Tokyo
TEL 03-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masakazu Miyajima
Organization Juntendo University
Division name Neurosurgery
Zip code
Address Hongo 2-1-1, Bunkyou-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email

Sponsor
Institute Study Group for normal pressure hydrocephalus granted by the Ministry of Health, Labor and Welfare of Japan
Institute
Department

Funding Source
Organization the Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation
2009 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
2010 Year 10 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information Neurological status before and after CSF tap test and at 6th months after shunt operation
Complications related shunt operation

Management information
Registered date
2009 Year 08 Month 24 Day
Last modified on
2009 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002916

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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