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

Phase 2

Completed

• Conditions: Idiopathic Normal Pressure Hydrocephalus

• Registration Number: NCT00221091
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Study Completion: 2005-10
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
modified Rankin scale

Secondary Outcome Measures

Name	Time	Method
cognitive function, NPH grading scale

Trial Locations

Locations (1)

Noto General Hospital; 🇯🇵 Nanao-shi, Ishikawa Pref., Japan