NCT00221091

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

February 9, 2009

Status Verified

February 1, 2009

First QC Date

September 13, 2005

Last Update Submit

February 6, 2009

Conditions

Idiopathic Normal Pressure Hydrocephalus

Keywords

idiopathic normal pressure hydrocephalusshunt

Outcome Measures

Primary Outcomes (1)

  • modified Rankin scale

Secondary Outcomes (1)

  • cognitive function, NPH grading scale

Interventions

ventriculo-peritoneal shuntPROCEDURE

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noto General Hospital

Nanao-shi, Ishikawa Pref., 926-8610, Japan

Location

Related Publications (5)

  • 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.

    PMID: 34795635DERIVED

  • 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.

    PMID: 28251346DERIVED

  • 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.

    PMID: 22239832DERIVED

  • 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.

    PMID: 21611722DERIVED

  • 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.

    PMID: 21040519DERIVED

Related Links

MeSH Terms

Interventions

Ventriculoperitoneal Shunt

Intervention Hierarchy (Ancestors)

Cerebrospinal Fluid ShuntsAnastomosis, SurgicalSurgical Procedures, OperativeNeurosurgical Procedures

Study Officials

  • Masatsune Ishikawa, M.D.

    Department of Neurosurgery, kitano Hospital, The Tazuke Kofukai Medical Research Institute. City: Osaka

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

September 1, 2004

Study Completion

October 1, 2005

Last Updated

February 9, 2009

Record last verified: 2009-02

Locations

JP(1)