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

NCT00874198 | Unknown

• 3 other identifiers: european-nph-study-01Dr.Klinge.C.T.Agreement08/2004Dr.Klinge.C.T.Agreement10/2006
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Pressure Hydrocephalus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale

  12 months

Secondary Outcomes (5)

• Neuropsychological measures (Stroop test, REy-auditory verbal learing test, PEG-BOARD TEST), Balance -score, Incontinence-score, Gait-score, Walking-score

  three and 12 months

• Balance -score

  three and 12 months

• Incontinence-score

  three and 12 months

• Gait-score

  three and 12 months

• Walking-score

  three and 12 months

Interventions

Ventriculo-peritoneal Shunt PROCEDURE

Surgical implantation of a ventriculo-peritoneal cerebrospinal fluid shunt with an adjustable valve system using the Codman-Hakim programmable valve system \[pressure settings: 30 - 200 mmH20\]

Also known as: see above

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• International Neuroscience Institute Hannover: lead
• Sahlgrenska University Hospital: collaborator
• Department of Neurology and Neurosurgery,Westeinde Hospital, Den Haag: collaborator
• Uppsala University Hospital: collaborator
• University of Copenhagen: collaborator
• Unfallkrankenhaus Berlin: collaborator
• Universität des Saarlandes: collaborator
• University of Padova: collaborator
• Masaryk University: collaborator
• University of Budapest: collaborator
• Hospital Universitari de Bellvitge: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator
• Neurosurgical Department, Clinique St. Jaen, Brussels, Belgium: collaborator

Study Sites (1)

International Neuroscience Institute Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (9)

• 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. doi: 10.1007/3-211-32318-x_48.

  PMID: 16463856 BACKGROUND

• 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. doi: 10.1097/00006123-200111000-00028.

  PMID: 11846911 BACKGROUND

• 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. doi: 10.3171/jns.1997.87.5.0687.

  PMID: 9347976 BACKGROUND

• 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. doi: 10.1136/jnnp.72.4.503.

  PMID: 11909911 BACKGROUND

• Wikkelso 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. doi: 10.1111/j.1600-0404.1986.tb04601.x.

  PMID: 3751498 BACKGROUND

• 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. doi: 10.1136/jnnp.51.4.521.

  PMID: 3379425 BACKGROUND

• Kahlon B, Sundbarg 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. doi: 10.1136/jnnp.73.6.721.

  PMID: 12438477 BACKGROUND

• 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.

  PMID: 12445344 BACKGROUND

• Wikkelso C, Hellstrom P, Klinge PM, Tans JT; European iNPH Multicentre Study Group. The European iNPH Multicentre Study on the predictive values of resistance to CSF outflow and the CSF Tap Test in patients with idiopathic normal pressure hydrocephalus. J Neurol Neurosurg Psychiatry. 2013 May;84(5):562-8. doi: 10.1136/jnnp-2012-303314. Epub 2012 Dec 18.

  PMID: 23250963 DERIVED

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Interventions

Ventriculoperitoneal Shunt

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cerebrospinal Fluid Shunts; Anastomosis, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: October 1, 2004
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2009
• Last Updated: April 3, 2009

Record last verified: 2009-04

Locations

DE (1)