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Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus (INPH)

This study has been terminated.
(observed benefit of treatment larger than expected)
Sponsor:
Information provided by:
University College London Hospitals
ClinicalTrials.gov Identifier:
NCT00727142
First received: July 29, 2008
Last updated: August 8, 2011
Last verified: July 2008
History of Changes
  Purpose

This study aims to provide class 1 evidence supporting or refuting the existence of normal pressure hydrocephalus.


Condition Intervention
Normal Pressure Hydrocephalus
 Procedure: Surgical treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus

Resource links provided by NLM:

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

Further study details as provided by University College London Hospitals:

Primary Outcome Measures:
  • improvement in walking speed [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improved cognition or continence [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: July 2008
Estimated Study Completion Date: July 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: open shunt
functioning shunt
 Procedure: Surgical treatment
Insertion of a functioning shunt
Other Name: Functioning shunt
Active Comparator: closed shunt
NON FUNCTIONING SHUNT
 Procedure: Surgical treatment
Insertion of a functioning shunt
Other Name: Functioning shunt

Detailed Description:

By comparing one group with active CSF shunting with another with non .

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic Normal pressure Hydrocephalus

Exclusion Criteria:

  • Alzheimer disease
  • Vascular dementia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727142

Locations
United Kingdom
National Hospital for Neurology and Neurosurgery
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
University College London Hospitals
Investigators
Principal Investigator: Laurence Watkins, FRCS NHNN
  More Information

No publications provided

Responsible Party: Mr Laurence Watkins, National Hospital for Neurology and Neurosurgery/Queen Square
ClinicalTrials.gov Identifier: NCT00727142     History of Changes
Other Study ID Numbers: 08/0149
Study First Received: July 29, 2008
Last Updated: August 8, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by University College London Hospitals:
NPH
Hydrocephalus
Shunt

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 June 17, 2013