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