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

Primary Purpose

Idiopathic Normal Pressure Hydrocephalus

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ventriculo-peritoneal shunt
Sponsored by
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Normal Pressure Hydrocephalus focused on measuring idiopathic normal pressure hydrocephalus, shunt

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Noto General Hospital

Outcomes

Primary Outcome Measures

modified Rankin scale

Secondary Outcome Measures

cognitive function, NPH grading scale

Full Information

First Posted
September 13, 2005
Last Updated
February 6, 2009
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Codman & Shurtleff, Johnson & Johnson, Nihon Medi-Physics Co., Ltd., Daiichi Pharmaceuticals, Eisai Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00221091
Brief Title
Study to Evaluate Efficacy of Shunt Operation for Idiopathic Normal Pressure Hydrocephalus
Official Title
Clinical Study of Idiopathic Normal Pressure Hydrocephalus for Neurological Improvement
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Codman & Shurtleff, Johnson & Johnson, Nihon Medi-Physics Co., Ltd., Daiichi Pharmaceuticals, Eisai Limited

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Normal Pressure Hydrocephalus
Keywords
idiopathic normal pressure hydrocephalus, shunt

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
ventriculo-peritoneal shunt
Primary Outcome Measure Information:
Title
modified Rankin scale
Secondary Outcome Measure Information:
Title
cognitive function, NPH grading scale

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masatsune Ishikawa, M.D.
Organizational Affiliation
Department of Neurosurgery, kitano Hospital, The Tazuke Kofukai Medical Research Institute. City: Osaka
Official's Role
Principal Investigator
Facility Information:
Facility Name
Noto General Hospital
City
Nanao-shi
State/Province
Ishikawa Pref.
ZIP/Postal Code
926-8610
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
34795635
Citation
Nakajima M, Yamada S, Miyajima M, Kawamura K, Akiba C, Kazui H, Mori E, Ishikawa M; SINPHONI-2 Investigators. Tap Test Can Predict Cognitive Improvement in Patients With iNPH-Results From the Multicenter Prospective Studies SINPHONI-1 and -2. Front Neurol. 2021 Nov 2;12:769216. doi: 10.3389/fneur.2021.769216. eCollection 2021.
Results Reference
derived
PubMed Identifier
28251346
Citation
Kameda M, Yamada S, Atsuchi M, Kimura T, Kazui H, Miyajima M, Mori E, Ishikawa M, Date I; SINPHONI and SINPHONI-2 Investigators. Cost-effectiveness analysis of shunt surgery for idiopathic normal pressure hydrocephalus based on the SINPHONI and SINPHONI-2 trials. Acta Neurochir (Wien). 2017 Jun;159(6):995-1003. doi: 10.1007/s00701-017-3115-2. Epub 2017 Mar 1.
Results Reference
derived
PubMed Identifier
22239832
Citation
Ishikawa M, Hashimoto M, Mori E, Kuwana N, Kazui H. The value of the cerebrospinal fluid tap test for predicting shunt effectiveness in idiopathic normal pressure hydrocephalus. Fluids Barriers CNS. 2012 Jan 13;9(1):1. doi: 10.1186/2045-8118-9-1.
Results Reference
derived
PubMed Identifier
21611722
Citation
Kawaguchi T, Hirata Y, Bundo M, Kondo T, Owaki H, Ito S, Hashimoto M, Ishikawa M. Role of computerized tomographic cisternography in idiopathic normal pressure hydrocephalus. Acta Neurochir (Wien). 2011 Oct;153(10):2041-8; discussion 2048. doi: 10.1007/s00701-011-1047-9. Epub 2011 May 25.
Results Reference
derived
PubMed Identifier
21040519
Citation
Hashimoto M, Ishikawa M, Mori E, Kuwana N; Study of INPH on neurological improvement (SINPHONI). Diagnosis of idiopathic normal pressure hydrocephalus is supported by MRI-based scheme: a prospective cohort study. Cerebrospinal Fluid Res. 2010 Oct 31;7:18. doi: 10.1186/1743-8454-7-18.
Results Reference
derived
Links:
URL
http://www.inph.jp/
Description
INPH(Idiopathic Normal Pressure Hydrocephalus)--only in Japanese

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

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