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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014