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European Study on Prediction of Outcome in Patients With Idiopathic Normal Pressure Hydrocephalus

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ClinicalTrials.gov Identifier: NCT00874198
Recruitment Status : Unknown
Verified April 2009 by International Neuroscience Institute Hannover.
Recruitment status was:  Active, not recruiting
First Posted : April 2, 2009
Last Update Posted : April 3, 2009
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Normal Pressure Hydrocephalus Procedure: Ventriculo-peritoneal Shunt

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: European Multicenter Study on the Prediction of Outcome in Patients With Idiopathic Normal Pressure Hydrocephalus
Study Start Date : October 2004
Primary Completion Date : March 2008
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Modified Rankin Scale [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Balance -score [ Time Frame: three and 12 months ]
  3. Incontinence-score [ Time Frame: three and 12 months ]
  4. Gait-score [ Time Frame: three and 12 months ]
  5. Walking-score [ Time Frame: three and 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874198

International Neuroscience Institute Hannover
Hannover, Lower Saxony, Germany, 30625
Sponsors and Collaborators
International Neuroscience Institute Hannover
Sahlgrenska University Hospital, 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
University of Budapest
Hospital Universitari de Bellvitge
Hospital General Universitario Gregorio Marañon
Neurosurgical Department, Clinique St. Jaen, Brussels, Belgium
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: April 3, 2009
Last Verified: April 2009

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

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