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

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ClinicalTrials.gov Identifier: NCT00221091
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 9, 2009
Sponsor:
Collaborators:
Codman & Shurtleff
Johnson & Johnson
NIHON MEDI-PHYSICS CO.,LTD.
Daiichi Pharmaceuticals
Eisai Limited
Information provided by:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
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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
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. modified Rankin scale

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

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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.

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00221091


Locations
Japan
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
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
INPH(Idiopathic Normal Pressure Hydrocephalus)--only in Japanese  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov 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 Center for Medical Innovation, Kobe, Hyogo, Japan:
idiopathic normal pressure hydrocephalus
shunt

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