European Study on Prediction of Outcome in Patients With Idiopathic Normal Pressure Hydrocephalus - Full Text View

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, Neurosurgical department, Germany Saarland University University of Padua Masaryk University Neurosurgical Department, University of Budapest, Hungary Neurosurgical Department, BEllvitge University, Barcelona, Spain Hospital General Universitario Gregorio Marañon Neurosurgical Department, Clinique St. Jaen, Brussels, Belgium
Information provided by:	International Neuroscience Institute Hannover
ClinicalTrials.gov Identifier:	NCT00874198

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:	Diagnostic, Single Blind (Investigator), Single Group Assignment, Efficacy Study
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 Surgery

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:

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]

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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, Lower Saxony
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, Neurosurgical department, Germany

Saarland University

University of Padua

Masaryk University

Neurosurgical Department, University of Budapest, Hungary

Neurosurgical Department, BEllvitge University, Barcelona, Spain

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

Additional Information:

homepage of the study - for more informatio please refer to pmklinge@gmail.com This link exits the ClinicalTrials.gov site

Publications:

Marmarou A, Black P, Bergsneider M, Klinge P, Relkin N; International NPH Consultant Group. Guidelines for management of idiopathic normal pressure hydrocephalus: progress to date. Acta Neurochir Suppl. 2005;95:237-40.

Hebb AO, Cusimano MD. Idiopathic normal pressure hydrocephalus: a systematic review of diagnosis and outcome. Neurosurgery. 2001 Nov;49(5):1166-84; discussion 1184-6. Review.

Boon AJ, Tans JT, Delwel EJ, Egeler-Peerdeman SM, Hanlo PW, Wurzer HA, Avezaat CJ, de Jong DA, Gooskens RH, Hermans J. Dutch normal-pressure hydrocephalus study: prediction of outcome after shunting by resistance to outflow of cerebrospinal fluid. J Neurosurg. 1997 Nov;87(5):687-93.

Walchenbach R, Geiger E, Thomeer RT, Vanneste JA. The value of temporary external lumbar CSF drainage in predicting the outcome of shunting on normal pressure hydrocephalus. J Neurol Neurosurg Psychiatry. 2002 Apr;72(4):503-6.

Wikkelsö C, Andersson H, Blomstrand C, Lindqvist G, Svendsen P. Normal pressure hydrocephalus. Predictive value of the cerebrospinal fluid tap-test. Acta Neurol Scand. 1986 Jun;73(6):566-73.

Tans JT, Poortvliet DC. Reduction of ventricular size after shunting for normal pressure hydrocephalus related to CSF dynamics before shunting. J Neurol Neurosurg Psychiatry. 1988 Apr;51(4):521-5.

Kahlon B, Sundbärg G, Rehncrona S. Comparison between the lumbar infusion and CSF tap tests to predict outcome after shunt surgery in suspected normal pressure hydrocephalus. J Neurol Neurosurg Psychiatry. 2002 Dec;73(6):721-6.

Zemack G, Romner B. Adjustable valves in normal-pressure hydrocephalus: a retrospective study of 218 patients. Neurosurgery. 2002 Dec;51(6):1392-400; discussion 1400-2.

Responsible Party:	International Neuroscience Institute Hannover ( Prof. Dr. med. Petra M. Klinge )
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
ClinicalTrials.gov Identifier:	NCT00874198 History of Changes
Health Authority:	Germany: Ethics Commission; Germany: German Institute of Medical Documentation and Information

Keywords provided by International Neuroscience Institute Hannover:

normal pressure hydrocephalus
cerebrospinal fluid dynamic test
cerebrospinal fluid outflow resistance
cerebrospinal compliance
outcome
shunt surgery

normal pressure hydrocephalus guidelines
biomarkers
shunt surgery selection
Outcome measures
Outcomes assessment
Outcome and process assessment

Study placed in the following topic categories:

Pseudotumor Cerebri
Infant, Newborn, Diseases
Central Nervous System Diseases
Hydrocephalus, Normal Pressure

Hydrocephalus
Brain Diseases
Intracranial Hypertension
Hypertension

Additional relevant MeSH terms:

Nervous System Diseases
Infant, Newborn, Diseases
Central Nervous System Diseases
Hydrocephalus, Normal Pressure

Hydrocephalus
Brain Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on September 11, 2009