UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008444 |
|---|---|
| Receipt number | R000009933 |
| Scientific Title | Japan Shunt Registry of Idiopathic Normal Pressure Hydrocephalus 2 |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2012/07/16 12:08:13 |
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Basic information
Public title
Japan Shunt Registry of Idiopathic Normal Pressure Hydrocephalus 2
Acronym
JSR2
Scientific Title
Japan Shunt Registry of Idiopathic Normal Pressure Hydrocephalus 2
Scientific Title:Acronym
JSR2
Region
| Japan |
Condition
Condition
Idiopathic Normal Pressure Hydrocephalus
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of verious shunt 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 sacle
Key secondary outcomes
Modified Ranking Scale
Care-giver's burden
Quality of life (EQ-5D)
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 (gait abnormalities, dementia, urinary control disturbance).
2. Ventriculomegary
Key exclusion criteria
Obstacles for six months follow-up
Secondary NPH
Target sample size
200
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, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakazu Miyajima |
Organization
Juntendo University
Division name
Neurosurgery
Zip code
Address
TEL
03-3813-3111
Homepage URL
mmasaka@juntendo.ac.jp
Sponsor or person
Institute
Study group for normal pressure hydrocephalus granted by the Ministry of Health, Labor and Welfare of Japan
Institute
Department
Personal name
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
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
| 2012 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Neurological status, daily function, quality of life and care-giver's burden
Complications related to shunt operation
Management information
Registered date
| 2012 | Year | 07 | Month | 16 | Day |
Last modified on
| 2012 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009933
