NCT01570257

Brief Summary

In treating idiopathic normal pressure hydrocephalus with a shunt there is always a risk of underdrainage or overdrainage. The hypothesis is tested whether treatment of patients with an adjustable valve preset at the highest opening pressure (OPV), leads to comparable clinical results with less subdural effusions than in a control group with an opening pressure preset and kept fixed at a low pressure level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
Last Updated

August 4, 2016

Status Verified

March 1, 2012

Enrollment Period

3.3 years

First QC Date

March 25, 2012

Last Update Submit

August 2, 2016

Conditions

Idiopathic Normal Pressure Hydrocephalus

Keywords

normal pressure hydrocephalusventriculoperitoneal shuntoverdrainagesubdural effusion

Outcome Measures

Primary Outcomes (1)

  • the number of Subdural effusions, detected on CT scan, in patients showing clinical improvement after implantation of a ventriculoperitoneal shunt,at the end of the study

    the most important parameter of the study will be the difference in incidence of subdural effusions between both groups

    baseline and 9 months (end of study)

Secondary Outcomes (6)

  • the final performance level of the valve of the shunt at the end of the study

    baseline and 9 months (end of study)

  • change in gait score

    baseline and 9 months (end of study)

  • change in urinary incontinence

    baseline and 9 months (end of study)

  • change in modified mini mental state (3MS) score

    baseline and 9 months (end of study)

  • change in modified Rankin (mRS) score

    baseline and 9 months (end of study)

  • +1 more secondary outcomes

Study Arms (2)

control group

NO INTERVENTION

These patients receive a shunt with the valve preset and fixed at a Performance level of 1.0, corresponding to an opening/closing pressure of 35-55 mm H2O.

Intervention group

EXPERIMENTAL

These patients receive a shunt with the valve preset at a Performance level (PL) of 2.5, corresponding to an opening/closing pressure of 135-155 mm H2O. The PL is allowed to be lowered until clinical improvement occurs.

Procedure: lowering of the performance level of an adjustable Strata valve in a ventriculoperitoneal (VP) shunt for treating idiopathic normal pressure hydrocephalus

Interventions

lowering of the performance level of an adjustable Strata valve in a ventriculoperitoneal (VP) shunt for treating idiopathic normal pressure hydrocephalusPROCEDURE

in the intervention group, the performance level(PL) of the valve of the VP shunt, preset at the highest PL (meaning highest resistance) is lowered stepwise in the follow-up period at 1,3 and 9 months postoperatively after implantation until improvement occurs or signs of overdrainage are encountered on a new CT scan of the brain. In the control group the PL is preset and fixed at the second lowest PL and these patients serve as a control group.

Also known as: PS Medical Strata I valve (small) (Medtronic, Goleta, USA)
Intervention group

Eligibility Criteria

AgeUp to 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • At least two out of three of the typical signs of normal pressure hydrocephalus:
  • gait disturbance,
  • cognitive impairment and
  • urinary incontinence.
  • Radiological verification of a communicating hydrocephalus.
  • Cerebrospinal fluid pressure at lumbar puncture \< 150 mm H2O.

You may not qualify if:

  • Aqueduct stenosis.
  • Severe comorbidity.
  • Age \> 85 years.
  • Possibly confounding neurological diseases.
  • Recent meningitis or subarachnoid hemorrhage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 CA, Netherlands

Location

MeSH Terms

Conditions

Hydrocephalus, Normal PressureSubdural Effusion

Condition Hierarchy (Ancestors)

HydrocephalusBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPerimeningeal InfectionsCentral Nervous System InfectionsInfections

Study Officials

  • Clemens MF Dirven, Prof. PhD

    Erasmus Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2012

First Posted

April 4, 2012

Study Start

September 1, 2003

Primary Completion

December 1, 2006

Study Completion

October 1, 2007

Last Updated

August 4, 2016

Record last verified: 2012-03

Locations

NL(1)