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 Informatics Center, 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.

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

Primary Outcome Measures :
  1. modified Rankin scale

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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
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

Noto General Hospital
Nanao-shi, Ishikawa Pref., Japan, 926-8610
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Codman & Shurtleff
Johnson & Johnson
Daiichi Pharmaceuticals
Eisai Limited
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): Identifier: NCT00221091     History of Changes
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 Informatics Center, Kobe, Hyogo, Japan:
idiopathic normal pressure hydrocephalus

Additional relevant MeSH terms:
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases