ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Study to Evaluate Efficacy of Shunt Operation for Idiopathic Normal Pressure Hydrocephalus

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Translational Research Informatics Center, Kobe, Hyogo, Japan
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
  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 II

MedlinePlus related topics:   Hydrocephalus    Surgery   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Clinical Study of Idiopathic Normal Pressure Hydrocephalus for Neurological Improvement

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

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.

  Eligibility
Ages Eligible for Study:   60 Years to 85 Years
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221091

Locations
Japan, Ishikawa Pref.
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

INPH(Idiopathic Normal Pressure Hydrocephalus)--only in Japanese  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   BRI NPH 03-01
First Received:   September 13, 2005
Last Updated:   July 3, 2006
ClinicalTrials.gov Identifier:   NCT00221091
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  

Study placed in the following topic categories:
Pseudotumor cerebri
Pseudotumor Cerebri
Infant, Newborn, Diseases
Central Nervous System Diseases
Hydrocephalus, Normal Pressure
Hydrocephalus
Brain Diseases
Intracranial Hypertension
Hypertension

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on July 18, 2008




Links to all studies - primarily for crawlers