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

This study is currently recruiting participants.

Verified by University College London Hospitals, July 2008

Sponsored by:	University College London Hospitals
Information provided by:	University College London Hospitals
ClinicalTrials.gov Identifier:	NCT00727142

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 Procedure: Conservative Treatment

MedlinePlus related topics: Hydrocephalus

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment
Official Title:	Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus

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 ]

Estimated Enrollment:	50
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
a: Active Comparator	Procedure: Surgical treatment Insertion of a functioning shunt
b: Placebo Comparator	Procedure: Conservative Treatment Placebo effect

Detailed Description:

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

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727142

Contacts

Contact: Laurence Watkins, FRCS	020 7837 3611 ext 4158	laurence.watkins@uclh.nhs.uk
Contact: Ahmed Toma, FRCS	020 7837 3611 ext 3225	ahmed.toma@uclh.nhs.uk

Locations

United Kingdom
National Hospital for Neurology and Neurosurgery	Recruiting
London, United Kingdom, WC1N 3BG
Principal Investigator: Laurence Watkins, FRCS
Sub-Investigator: Ahmed Toma, FRCS

Sponsors and Collaborators

University College London Hospitals

Investigators

Principal Investigator:

Laurence Watkins, FRCS

NHNN

More Information

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

Keywords provided by University College London Hospitals:

NPH
Hydrocephalus
Shunt

Study placed in the following topic categories:

Pseudotumor cerebri
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

ClinicalTrials.gov processed this record on January 14, 2009