Status:
UNKNOWN
European Study on Prediction of Outcome in Patients With Idiopathic Normal Pressure Hydrocephalus
Lead Sponsor:
International Neuroscience Institute Hannover
Collaborating Sponsors:
Sahlgrenska University Hospital
Department of Neurology and Neurosurgery,Westeinde Hospital, Den Haag
Conditions:
Normal Pressure Hydrocephalus
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
Study background: The selection of patients with idiopathic normal pressure hydrocephalus (INPH) for shunting remains difficult. The upcoming guidelines for the diagnosis and management of INPH state...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00874198
Start Date
October 1 2004
End Date
June 1 2009
Last Update
April 3 2009
Active Locations (1)
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1
International Neuroscience Institute Hannover
Hanover, Lower Saxony, Germany, 30625