Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00221091
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 9, 2009
Codman & Shurtleff
Johnson & Johnson
Daiichi Pharmaceuticals
Eisai Limited
Information provided by:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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.

Condition or disease Intervention/treatment Phase
Idiopathic Normal Pressure Hydrocephalus Procedure: ventriculo-peritoneal shunt Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Idiopathic Normal Pressure Hydrocephalus for Neurological Improvement
Study Start Date : September 2004
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

Primary Outcome Measures :
  1. modified Rankin scale

Secondary Outcome Measures :
  1. cognitive function, NPH grading scale

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00221091

Layout table for location information
Noto General Hospital
Nanao-shi, Ishikawa Pref., Japan, 926-8610
Sponsors and Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Codman & Shurtleff
Johnson & Johnson
Daiichi Pharmaceuticals
Eisai Limited
Layout table for investigator information
Principal Investigator: Masatsune Ishikawa, M.D. Department of Neurosurgery, kitano Hospital, The Tazuke Kofukai Medical Research Institute. City: Osaka

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00221091    
Other Study ID Numbers: BRI NPH 03-01
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: February 2009
Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:
idiopathic normal pressure hydrocephalus
Additional relevant MeSH terms:
Layout table for MeSH terms
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases