A Trial of High and Low Pressure Level Settings on a Programmable Ventriculoperitoneal Shunt Valve for Idiopathic Normal Pressure Hydrocephalus
Primary Purpose
Idiopathic Normal Pressure Hydrocephalus
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
lowering of the performance level of an adjustable Strata valve in a ventriculoperitoneal (VP) shunt for treating idiopathic normal pressure hydrocephalus
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Normal Pressure Hydrocephalus focused on measuring normal pressure hydrocephalus, ventriculoperitoneal shunt, overdrainage, subdural effusion
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- Aqueduct stenosis.
- Severe comorbidity.
- Age > 85 years.
- Possibly confounding neurological diseases.
- Recent meningitis or subarachnoid hemorrhage.
Sites / Locations
- Erasmus Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
Intervention group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
the final performance level of the valve of the shunt at the end of the study
Peformance level is the opening/closing pressure of the valve and reflects the hydrostatic resistance of the valve of the shunt
change in gait score
change in urinary incontinence
change in modified mini mental state (3MS) score
the 3MS score quantifies cognitive function
change in modified Rankin (mRS) score
the mRS quantifies functional impairment
change in Evans' ratio
a measure of ventricular width, on CT scan
Full Information
NCT ID
NCT01570257
First Posted
March 25, 2012
Last Updated
August 2, 2016
Sponsor
Erasmus Medical Center
Collaborators
Isala, Albert Schweitzer Hospital, UMC Utrecht, Atrium Medical Center, University Medical Center Nijmegen, Admiraal de Ruyter Hospital, Goes, the Netherlands, Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT01570257
Brief Title
A Trial of High and Low Pressure Level Settings on a Programmable Ventriculoperitoneal Shunt Valve for Idiopathic Normal Pressure Hydrocephalus
Official Title
A Randomized Trial of High and Low Pressure Level Settings on a Programmable Ventriculoperitoneal Shunt Valve for Idiopathic Normal Pressure Hydrocephalus. Results of the Dutch Evaluation Program Strata Shunt (DEPSS) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Isala, Albert Schweitzer Hospital, UMC Utrecht, Atrium Medical Center, University Medical Center Nijmegen, Admiraal de Ruyter Hospital, Goes, the Netherlands, Medtronic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Idiopathic normal pressure hydrocephalus (INPH) is characterized by a clinical triad of symptoms: gait disturbance, urinary incontinence and cognitive impairment. INPH typically develops among the elderly and shares some symptoms with other neurological disorders. In general, 60-70% of patients with the complete clinical triad and signs of hydrocephalus on CT/MRI will improve after cerebrospinal fluid (CSF) shunting. Implantation of a shunt, however, carries complications such as infection, obstruction, underdrainage, and overdrainage. The cumulative complication rate and revision rate is estimated to be 35-80% among adults. The England shunt registry described an overall incidence of underdrainage of 52%, and studies have resulted in incidences of overdrainage between 2 and 21%. Børgesen claims that 80% of complications of shunting for INPH are related to overdrainage. Overdrainage may lead to low intracranial pressure syndrome and subdural effusions (SDE). Low intracranial pressure syndrome is characterized by orthostatic headaches and sometimes nausea, vomiting, drowsiness, diplopia, upward gaze palsy and visual defects. As INPH patients are often elderly patients with concomitant brain atrophy and normal CSF pressure they are especially at risk for developing signs and symptoms of overdrainage.
Overdrainage can be prevented or treated by implanting an anti-siphon device (ASD) or changing the opening pressure of the valve (OPV). Different ASDs have been developed since the first publication in 1973. They have in common that the lumen of the catheter is closed under influence of a negative hydrostatic pressure at the level of the ASD. The optimal valve setting for treating INPH is still the subject of controversy. The dilemma in INPH patients is that a low OPV might lead to overdrainage-related symptoms. A high valve setting might lead to underdrainage and the patient misses the chance of maximum improvement.
Studies examining whether to use a low or high OPV have been contradictory so far.
After randomization, baseline primary and secondary outcome measure assessments are conducted preoperatively. Within 24 hours of shunting, skull, thoracic, and abdominal X-rays are done to verify device connections and position. Follow-up visits at 1, 3, and 9 months include all primary and secondary outcome assessments. All measurements are done by a research assistant who visits the participating hospitals to prevent inter-observer variation. Study end for each patient is defined as completing the 9 month visit or death, detection of SDE on CT, or shunt removal or revision due to infection or dysfunction.
The PL in Group 1 (control group) is allowed to be increased to a higher setting when an SDE is detected. The patient thereby reaches study end, and the treating physician is free to decide how to manage the PL. The 9-month follow-up is still obtained. The PL in Group 2 is preset at the highest PL and eventually lowered 1 step at each follow-up visit when the modified mini mental state (3MS) or Gait score is not increased ≥ 15% provided that no SDE is visible on a new CT scan. The 15% is considered the minimum percentage to reliably determine improvement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Normal Pressure Hydrocephalus
Keywords
normal pressure hydrocephalus, ventriculoperitoneal shunt, overdrainage, subdural effusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
lowering of the performance level of an adjustable Strata valve in a ventriculoperitoneal (VP) shunt for treating idiopathic normal pressure hydrocephalus
Other Intervention Name(s)
PS Medical Strata I valve (small) (Medtronic, Goleta, USA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
the most important parameter of the study will be the difference in incidence of subdural effusions between both groups
Time Frame
baseline and 9 months (end of study)
Secondary Outcome Measure Information:
Title
the final performance level of the valve of the shunt at the end of the study
Description
Peformance level is the opening/closing pressure of the valve and reflects the hydrostatic resistance of the valve of the shunt
Time Frame
baseline and 9 months (end of study)
Title
change in gait score
Time Frame
baseline and 9 months (end of study)
Title
change in urinary incontinence
Time Frame
baseline and 9 months (end of study)
Title
change in modified mini mental state (3MS) score
Description
the 3MS score quantifies cognitive function
Time Frame
baseline and 9 months (end of study)
Title
change in modified Rankin (mRS) score
Description
the mRS quantifies functional impairment
Time Frame
baseline and 9 months (end of study)
Title
change in Evans' ratio
Description
a measure of ventricular width, on CT scan
Time Frame
baseline and 9 months (end of study)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Aqueduct stenosis.
Severe comorbidity.
Age > 85 years.
Possibly confounding neurological diseases.
Recent meningitis or subarachnoid hemorrhage.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clemens MF Dirven, Prof. PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3015 CA
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
A Trial of High and Low Pressure Level Settings on a Programmable Ventriculoperitoneal Shunt Valve for Idiopathic Normal Pressure Hydrocephalus
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