Status:
COMPLETED
Study to Evaluate Efficacy of Shunt Operation for Idiopathic Normal Pressure Hydrocephalus
Lead Sponsor:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborating Sponsors:
Codman & Shurtleff
Johnson & Johnson
Conditions:
Idiopathic Normal Pressure Hydrocephalus
Eligibility:
All Genders
60-85 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00221091
Start Date
September 1 2004
End Date
October 1 2005
Last Update
February 9 2009
Active Locations (1)
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1
Noto General Hospital
Nanao-shi, Ishikawa Pref., Japan, 926-8610