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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002730
Receipt No. R000003260
Scientific Title Study of Idiopathic Normal Pressure Hydrocephalus on Neurological Improvement-Part 2 -Effeciveness and safety of lumboperitoneal shunt -
Date of disclosure of the study information 2010/02/01
Last modified on 2011/11/11

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Basic information
Public title Study of Idiopathic Normal Pressure Hydrocephalus on Neurological Improvement-Part 2 -Effeciveness and safety of lumboperitoneal shunt -
Acronym SINPHONI-2
Scientific Title Study of Idiopathic Normal Pressure Hydrocephalus on Neurological Improvement-Part 2 -Effeciveness and safety of lumboperitoneal shunt -
Scientific Title:Acronym SINPHONI-2
Region
Japan

Condition
Condition Idiopathic Normal Pressure Hydrocephalus
Classification by specialty
Neurology Radiology Neurosurgery
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the efficacy and safety of lumboperitoneal shunt for idiopathic normal pressure hydrocephalus in a randomized controlledl trial
Basic objectives2 Others
Basic objectives -Others To assess long-term benefits of lumboperitoneal shunt for idiopathic normal pressure hydrocephalus
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes More than 1 level improvement on modified Rankin scale 3 months after randomization, and prevalence of safety issues
Key secondary outcomes 1) Improvement of gait, cognitive, and urinary dysfunction 3 months after randomization measured with the iNPH grading scale, 3-meter timed up and go test, frontal assessment battery, and so on
2) More than 1 level improvement on modified Rankin scale 1 year after cerebrospinal fluid shunt
3) Cerebral blood flow measurement by IMP-SPECT

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 To assess an incidence of one point or more improvement on modified Rankin scale at 3 months after waiting with rehabilitation in idiopathic normal pressure hydrocephalus
Interventions/Control_2 To assess an incidence of one point or more improvement on modified Rankin scale at 3 months after the LP shunt in idiopathic normal pressure hydrocephalus
Interventions/Control_3 To make historical comparison with the VP shunt data of SINPHONI, if a statistical difference on modified Rankin scale is not found between two groups at 12 months after the LP shunt
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) 60 - 85 years old
2)one or more of NPH triad (gait, cognition, urination)
3)ventriculomegaly (Evans index > 0.3)
4)high convexity tightness in coronal MRI
5)idiopathic
Key exclusion criteria 1) unpromising improvement due to motor, visceral or psychiatric disorders
2)association with malignancy or difficulty in one-year follow-up
3)hemorrhagic diathesis, coagulopathy or hemorrhagic disorders(intracerebral hemorrhage, subarachnoid hemorrhage)
4)hepatic failure
5)renal failure requiring artificial dialysis
6)planned major surgery during the study period
7)on medication with anticoagulant or antiplatelet agents without interruption
8)history of major abdominal surgery or lumbago
9)unsuitable by the decision of doctors
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name 1)Masatsune Ishikawa, 2)Etsuro Mori
Organization 1)Rakuwakai Otowa Hospital
2)Tohoku University Graduate School of Medicine
Division name 1) Normal Pressure Hydrocephalus Center 2) Behavioral Neurology
Zip code
Address 1)2 Chinjicho Otowa Yamashina, Kyoto, 2)2-1 Seiryocho, Aobaku, Sendai 2) 2-1 Seiryocho Aobaku Sendai
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization 1)Rakuwakai Otowa Hospital 2)Tohoku University, Graduate School of Medicine
Division name 1)Normal Pressure Hydrocephalus Center 2)Behavioral Neurology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Japan Society of Normal Pressure Hydrocephalus
Institute
Department

Funding Source
Organization Japan Society of Normal Pressure Hydrocephalus
Organization
Division
Category of Funding Organization Self funding
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
2010 Year 02 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 No longer recruiting
Date of protocol fixation
2009 Year 11 Month 19 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
2012 Year 09 Month 01 Day
Date trial data considered complete
2012 Year 09 Month 01 Day
Date analysis concluded
2012 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 11 Month 09 Day
Last modified on
2011 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003260

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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