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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Idiopathic Normal Pressure Hydrocephalus | Procedure: ventriculo-peritoneal shunt | Phase 2 |
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 |

- modified Rankin scale
- cognitive function, NPH grading scale

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Ages Eligible for Study: | 60 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Japan | |
Noto General Hospital | |
Nanao-shi, Ishikawa Pref., Japan, 926-8610 |
Principal Investigator: | Masatsune Ishikawa, M.D. | Department of Neurosurgery, kitano Hospital, The Tazuke Kofukai Medical Research Institute. City: Osaka |
Additional Information:
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 |