Idiopathic Normal Pressure HydrocephalusPhase 2NCT00221091
Study to Evaluate Efficacy of Shunt Operation for Idiopathic Normal Pressure Hydrocephalus
A Phase 2 study testing ventriculo-peritoneal shunt in people with Idiopathic Normal Pressure Hydrocephalus, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Idiopathic Normal Pressure Hydrocephalus
- What is being tested?
- ventriculo-peritoneal shunt
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2004to Oct 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of Idiopathic Normal Pressure Hydrocephalus for Neurological Improvement
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.
Read the 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.
- Conditions
- Idiopathic Normal Pressure Hydrocephalus
- Being tested
- ventriculo-peritoneal shunt
- Keywords
- idiopathic normal pressure hydrocephalus, shunt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventriculo-peritoneal shuntProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin scale
Secondary outcomes (1)
cognitive function, NPH grading scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2004
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Codman & Shurtleff, Johnson & Johnson, Nihon Medi-Physics Co., Ltd., Daiichi Pharmaceuticals, Eisai Limited
- Investigators
- Masatsune Ishikawa, M.D., Principal investigator, Department of Neurosurgery, kitano Hospital, The Tazuke Kofukai Medical Research Institute. City: Osaka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221091
- Sponsor's protocol ID
- BRI NPH 03-01
- Status last verified
- Feb 2009
- First submitted
- 13 Sep 2005
- Last updated
- 9 Feb 2009
- Results posted
- No
Publications
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.
PubMed 34795635Kameda 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.
PubMed 28251346Ishikawa 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.
PubMed 22239832Kawaguchi 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.
PubMed 21611722Hashimoto 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.
PubMed 21040519
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Idiopathic Normal Pressure Hydrocephalus for Neurological Improvement
- ClinicalTrials.gov ID
- NCT00221091
- Acronym / sponsor ID
- BRI NPH 03-01
- Conditions
- Idiopathic Normal Pressure Hydrocephalus
- Keywords
- idiopathic normal pressure hydrocephalus, shunt
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Codman & Shurtleff, Johnson & Johnson, Nihon Medi-Physics Co., Ltd., Daiichi Pharmaceuticals, Eisai Limited
- Study start
- Sep 2004
- Study completion
- Oct 2005
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ventriculo-peritoneal shunt | Procedure or surgery | – |
Primary outcome
modified Rankin scale
1 secondary outcome
cognitive function, NPH grading scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
- Derived from this study: PubMed 34795635Nakajima 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.
- Derived from this study: PubMed 28251346Kameda 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.
- Derived from this study: PubMed 22239832Ishikawa 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.
- Derived from this study: PubMed 21611722Kawaguchi 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.
- Derived from this study: PubMed 21040519Hashimoto 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.
- INPH(Idiopathic Normal Pressure Hydrocephalus)--only in JapaneseLink provided by the sponsor.
Related trials for Idiopathic Normal Pressure Hydrocephalus
Not yet recruitingObservational study
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
Idiopathic Normal Pressure Hydrocephalus, Normal Pressure Hydrocephalus
Not yet recruitingObservational study
Transcranial Ultrasound Assessment of Cerebral Pulsatility in Shunt Decision-making for Suspected Idiopathic Normal Pressure Hydrocephalus: a Prospective Cohort Study
Brain Pulsatility, Idiopathic Normal Pressure Hydrocephalus (INPH)
Enrolling by invitationObservational study
Unsteady Gait in Older People May be a Common and Treatable Neurological Disease Associated With Increased Mortality
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Recruiting
Multi-omics Research of Idopathic Normal Pressure Hydrocephalus (iNPH)
Idiopathic Normal Pressure Hydrocephalus
RecruitingObservational study
White Matter Distortion and Dementia Biomarkers in Normal Pressure Hydrocephalus (NPH)
Normal Pressure Hydrocephalus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masatsune Ishikawa, M.D. principal investigator
Department of Neurosurgery, kitano Hospital, The Tazuke Kofukai Medical Research Institute. City: Osaka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ventriculo-peritoneal shunt in people with Idiopathic Normal Pressure Hydrocephalus, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin scale. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00221091, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2009.