Study to Evaluate Efficacy of Shunt Operation for Idiopathic Normal Pressure Hydrocephalus
This study has been completed.
Sponsor:
Translational Research Informatics Center, Kobe, Hyogo, Japan
Collaborators:
Codman & Shurtleff
Johnson & Johnson
NIHON MEDI-PHYSICS CO.,LTD.
Daiichi Pharmaceuticals
Eisai Limited
Information provided by:
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00221091
First received: September 13, 2005
Last updated: February 6, 2009
Last verified: February 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Idiopathic Normal Pressure Hydrocephalus |
Procedure: ventriculo-peritoneal shunt |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical Study of Idiopathic Normal Pressure Hydrocephalus for Neurological Improvement |
Resource links provided by NLM:
Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
Primary Outcome Measures:
- modified Rankin scale
Secondary Outcome Measures:
- cognitive function, NPH grading scale
| Estimated Enrollment: | 110 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | October 2005 |
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.
Eligibility| Ages Eligible for Study: | 60 Years to 85 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00221091
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221091
Locations
| Japan | |
| Noto General Hospital | |
| Nanao-shi, Ishikawa Pref., Japan, 926-8610 | |
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Codman & Shurtleff
Johnson & Johnson
NIHON MEDI-PHYSICS CO.,LTD.
Daiichi Pharmaceuticals
Eisai Limited
Investigators
| Principal Investigator: | Masatsune Ishikawa, M.D. | Department of Neurosurgery, kitano Hospital, The Tazuke Kofukai Medical Research Institute. City: Osaka |
More Information
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 |
| Study First Received: | September 13, 2005 |
| Last Updated: | February 6, 2009 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare Japan: Ministry of Education, Culture, Sports, Science and Technology |
Keywords provided by Translational Research Informatics Center, 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 |
ClinicalTrials.gov processed this record on September 28, 2016