UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002730 |
|---|---|
| Receipt number | 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 08:56:02 |
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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
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
Sponsor or person
Institute
Japan Society of Normal Pressure Hydrocephalus
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003260
