NCT00727142

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

3.1 years

First QC Date

July 29, 2008

Last Update Submit

May 10, 2018

Conditions

Normal Pressure Hydrocephalus

Keywords

NPHHydrocephalusShunt

Outcome Measures

Primary Outcomes (1)

  • improvement in walking speed

    3 months

Secondary Outcomes (1)

  • improved cognition or continence

    3 months

Study Arms (2)

open shunt

ACTIVE COMPARATOR

functioning shunt

Procedure: Surgical treatment

closed shunt

ACTIVE COMPARATOR

NON FUNCTIONING SHUNT

Procedure: Surgical treatment

Interventions

Surgical treatmentPROCEDURE

Insertion of a functioning shunt

Also known as: Functioning shunt
closed shuntopen shunt

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Normal pressure Hydrocephalus

You may not qualify if:

  • Alzheimer disease
  • Vascular dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Hospital for Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

Location

MeSH Terms

Conditions

Hydrocephalus, Normal PressureHydrocephalus

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Laurence Watkins, FRCS

    NHNN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Neurosurgeon

Study Record Dates

First Submitted

July 29, 2008

First Posted

August 1, 2008

Study Start

July 1, 2008

Primary Completion

August 1, 2011

Study Completion

July 1, 2012

Last Updated

May 16, 2018

Record last verified: 2018-05

Locations

GB(1)