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Trial record 2 of 58 for:    Hydrocephalus
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European Study on Prediction of Outcome in Patients With Idiopathic Normal Pressure Hydrocephalus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by International Neuroscience Institute Hannover.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Neurological Institute of Sahlgrenska University Götheborg, Sweden
Department of Neurology and Neurosurgery,Westeinde Hospital, Den Haag
Uppsala University Hospital
University of Copenhagen
Unfallkrankenhaus Berlin
Saarland University
University of Padua
Masaryk University
Neurosurgical Department, University of Budapest, Hungary
Hospital Universitari de Bellvitge
Hospital General Universitario Gregorio Marañon
Neurosurgical Department, Clinique St. Jaen, Brussels, Belgium
Information provided by:
International Neuroscience Institute Hannover
ClinicalTrials.gov Identifier:
NCT00874198
First received: April 1, 2009
Last updated: April 2, 2009
Last verified: April 2009
History of Changes
  Purpose

The purpose of the study is to determine the predictive values and prognostic accuracies of CSF dynamic measures, the TAP -TEST (high-volume cerebrospinal fluid withdrawal), resistance to CSF outflow and compliance in the prediction of shunt-treatment outcome in patients with idiopathic normal pressure hydrocephalus.


Condition Intervention
Normal Pressure Hydrocephalus
 Procedure: Ventriculo-peritoneal Shunt

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: European Multicenter Study on the Prediction of Outcome in Patients With Idiopathic Normal Pressure Hydrocephalus

Resource links provided by NLM:

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

Further study details as provided by International Neuroscience Institute Hannover:

Primary Outcome Measures:
  • Modified Rankin Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuropsychological measures (Stroop test, REy-auditory verbal learing test, PEG-BOARD TEST), Balance -score, Incontinence-score, Gait-score, Walking-score [ Time Frame: three and 12 months ] [ Designated as safety issue: No ]
  • Balance -score [ Time Frame: three and 12 months ] [ Designated as safety issue: No ]
  • Incontinence-score [ Time Frame: three and 12 months ] [ Designated as safety issue: No ]
  • Gait-score [ Time Frame: three and 12 months ] [ Designated as safety issue: No ]
  • Walking-score [ Time Frame: three and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 156
Study Start Date: October 2004
Estimated Study Completion Date: June 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Ventriculo-peritoneal Shunt
    Surgical implantation of a ventriculo-peritoneal cerebrospinal fluid shunt with an adjustable valve system using the Codman-Hakim programmable valve system [pressure settings: 30 - 200 mmH20]
    Other Name: see above
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis (neurological and radiological criteria) of idiopathic normal pressure hydrocephalus

Typical INPH

Clinical criteria:

  • Gradually developed gait disturbance of both legs, unexplained by other conditions. Disturbance of tandem walking, multi-step turning, small steps and wide base must be present at least.
  • MMSE score 21-30 without aphasia, apraxia and agnosia
  • Bladder instability and postural instability may be present.

Radiological criteria (MRI):

  • Symmetrical communicating quadri-ventricular enlargement without cortical infarcts or other clinically relevant parenchymal lesions but lacunar infarcts of less than 1 cc may be present
  • Evans index > 0.30 and temporal horns and third ventricle relatively enlarged.
  • Mild cortical atrophy and mild leuco-araiosis may be present.

Questionable NPH

Clinical criteria:

  • Any gait disturbance of both legs that does not fulfill the criteria of typical INPH, but is compatible with INPH.
  • MMSE score < 21
  • Bladder instability and postural instability may be present.

Radiological criteria (MRI):

  • Symmetrical communicating quadri-ventricular enlargement without major parenchymal lesions. Single cortical infarcts and lacunar infarcts may be present.
  • Evans index > 0.30.
  • Moderate cortical atrophy and moderate to severe leuco-araiosis may be present.

Exclusion Criteria:

  • Secondary Normal pressure Hydrocephalus
  • Non-communicating hydrocephalus
  • Secondary NPH (after SAH, trauma, infection, neurosurgical procedure). Trauma or infection are regarded as relevant if the patient was unconscious in relation to the trauma or required hospitalisation for his meningo-encephalitis.
  • INPH-patients later shown to have ICP > 18 mm Hg.
  • Contra-indications to surgery.
  • Patients refusing shunt surgery
  • Restricted life-expectancy
  • Patients not capable of managing the tests or investigations at entry of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874198

Locations
Germany
International Neuroscience Institute Hannover
Hannover, Lower Saxony, Germany, 30625
Sponsors and Collaborators
International Neuroscience Institute Hannover
Neurological Institute of Sahlgrenska University Götheborg, Sweden
Department of Neurology and Neurosurgery,Westeinde Hospital, Den Haag
Uppsala University Hospital
University of Copenhagen
Unfallkrankenhaus Berlin
Saarland University
University of Padua
Masaryk University
Neurosurgical Department, University of Budapest, Hungary
Hospital Universitari de Bellvitge
Hospital General Universitario Gregorio Marañon
Neurosurgical Department, Clinique St. Jaen, Brussels, Belgium
Investigators
Principal Investigator: Petra M Klinge, MD International Neuroscience Institute Hannover
Principal Investigator: Carsten I Wikkelsoe, MD Sahlgrenska University, Gothenburg, Sweden
Principal Investigator: Jos TH Tans, MD Westeinde Hospital, Den Haag, Netherlands
  More Information

Publications:

Responsible Party: Prof. Dr. med. Petra M. Klinge, International Neuroscience Institute Hannover
ClinicalTrials.gov Identifier: NCT00874198     History of Changes
Other Study ID Numbers: european-nph-study-01, Dr.Klinge.C.T.Agreement08/2004, Dr.Klinge.C.T.Agreement10/2006
Study First Received: April 1, 2009
Last Updated: April 2, 2009
Health Authority: Germany: Ethics Commission
Germany: German Institute of Medical Documentation and Information

Keywords provided by International Neuroscience Institute Hannover:
normal pressure hydrocephalus
normal pressure hydrocephalus guidelines
cerebrospinal fluid dynamic test
cerebrospinal fluid outflow resistance
cerebrospinal compliance
outcome
 shunt surgery
biomarkers
shunt surgery selection
Outcome measures
Outcomes assessment
Outcome and process assessment

Additional relevant MeSH terms:
Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on May 16, 2013