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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Summary: 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.
Sponsor: Translational Research Informatics Center, Kobe, Hyogo, Japan

Current Primary Outcome: modified Rankin scale

Original Primary Outcome: Same as current

Current Secondary Outcome: cognitive function, NPH grading scale

Original Secondary Outcome: Same as current

Information By: Translational Research Informatics Center, Kobe, Hyogo, Japan

Dates:
Date Received: September 13, 2005
Date Started: September 2004
Date Completion: October 2005
Last Updated: February 6, 2009
Last Verified: February 2009