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Study to Evaluate Efficacy of Shunt Operation for Idiopathic Normal Pressure Hydrocephalus

This study is ongoing, but not recruiting participants.
Information provided by Translational Research Informatics Center, Kobe, Hyogo, Japan

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Descriptive Information Fields
Brief Title  Study to Evaluate Efficacy of Shunt Operation for Idiopathic Normal Pressure Hydrocephalus
Official Title  Clinical Study of Idiopathic Normal Pressure Hydrocephalus for Neurological Improvement
Brief Summary

This study evaluates the efficacy of shunt operation for idiopathic normal pressure hydrocephalus, and determines the diagnostic value of noninvasive procedures commonly practiced in the clinic.

Detailed Description

Idiopathic normal pressure hydrocephalus (iNPH) is a syndrome characterized by ventricular dilatation due to disturbed cerebrospinal fluid (CSF) circulation, accompanied by gait disturbance, dementia and/or urinary incontinence without causative disorders. With the aging of Japanese society, the number of patients is increasing, requiring diagnostic and therapeutic guidelines for the improvement of the patients’ quality of life and social care. Under such conditions, this project was made as the prospective study of iNPH on Neurological Improvement (SINPHONI ). This study aims 1) to establish methods for non-invasive diagnosis of iNPH, and 2) to demonstrate therapeutic outcome of shunting operation by Codman Hakim programmable valve (CHPV). In this protocol, the evaluation of validity on MRI, tap test, CT cisternography, and CBF (3D-SSP) will be done in the diagnosis, and manual of initial setting pressure in CHPV for prevention of overdrainage problems will be estimated by modified Rankin scale (as primary endpoint) and some another scales during 1 year.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  modified Rankin scale
Secondary Outcome Measure  cognitive function, NPH grading scale
Condition  Idiopathic Normal Pressure Hydrocephalus
Intervention  Procedure: ventriculo-peritoneal shunt
MEDLINE PMIDs
Links INPH(Idiopathic Normal Pressure Hydrocephalus)--only in Japanese This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  110
Start Date  September 2004
Completion Date October 2005
Eligibility Criteria 

Inclusion Criteria:

Patients who had at least one more points of the triad (gait disturbance, cognitive impairment, and urinary incontinence) in Japan NPH grading scale revised, and had disproportionate ventriculomegaly (Evans index >0.3) with closing of the CSF space at high convexity on MRI. These patients must be diagnosed clinically other causative disorders, and ventricular dilatation due to disturbance of the cerebrospinal fluid (CSF) circulation. Be able to give informed consent.

Exclusion Criteria:

1) Cannot have an MRI scan 2) Has a problem with bleeding tendency and other serological examination. (liver enzyme and renal dysfunction, blood coagulopathy, and etc.) 3) Is unable to understand the risks of the testing and surgical therapy. 4) is tolerable for one year follow up after shunting operation.

Gender Both
Ages 60 Years to 85 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Japan
Administrative Information Fields
NCT ID  NCT00221091
Organization ID BRI NPH 03-01
Secondary IDs ††
Study Sponsor  Translational Research Informatics Center, Kobe, Hyogo, Japan
Collaborators †† Codman & Shurtleff
Johnson & Johnson
NIHON MEDI-PHYSICS CO.,LTD.
Daiichi Pharmaceuticals
Eisai Limited
Investigators 
Principal Investigator:     Masatsune Ishikawa, M.D.     Department of Neurosurgery, kitano Hospital, The Tazuke Kofukai Medical Research Institute. City: Osaka    
Information Provided By Translational Research Informatics Center, Kobe, Hyogo, Japan
Verification Date July 2006
First Received Date  September 13, 2005
Last Updated Date July 3, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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