Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus
Primary Purpose
Normal Pressure Hydrocephalus
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Endoscopic Third Ventriculostomy
Ventriculo-Peritoneal Shunting
Sponsored by
About this trial
This is an interventional treatment trial for Normal Pressure Hydrocephalus focused on measuring endoscopic third ventriculostomy, ventricular peritoneal shunt, communicating hydrocephalus
Eligibility Criteria
Inclusion Criteria:
- Age over 50 years
- gait disturbances typical for iNPH
- symptoms Duration less than 36months
- exclusion of obstructive hydrocephalus
- positive spinal TAP-test
Exclusion Criteria:
- no informed consent
- malignant disease
- other diseases of the CNS (Parkinson, dementia)
- secondary communicating hydrocephalus
Sites / Locations
- University Medicine GreifswaldRecruiting
- University Medicine Göttingen
- Klinikum NeubrandenburgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
endoscopic third ventriculostomy
ventricular peritoneal shunt
Arm Description
endoscopic third ventriculostomy for the treatment of iNPH
Insertion of a ventriculo-peritoneal Shunt for the treatment of iNPH
Outcomes
Primary Outcome Measures
Kiefer Index
Improvment of at least 2 points
Recovery Index
Improvment of at least 2 points
Secondary Outcome Measures
Full Information
NCT ID
NCT03245138
First Posted
July 31, 2017
Last Updated
November 5, 2018
Sponsor
University Medicine Greifswald
1. Study Identification
Unique Protocol Identification Number
NCT03245138
Brief Title
Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus
Official Title
Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medicine Greifswald
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
An endoscopic third ventriculostomy is considered to be successful in idiopathic normal pressure hydrocephalus (iNPH) in some literature reports, but there is a lack of high quality data. The aim of the present study is to compare the treatment options of iNPH (Endoscopic third ventriculostomy versus ventriculo-peritoneal shunt) in a randomized, controlled, multicenter study.
Detailed Description
The traditional treatment for communicating hydrocephalus is a ventriculo-peritoneal shunt insertion and the endoscopic third ventriculostomy (ETV) is reserved for patients with obstructive hydrocephalus. However, in the last decade several reports highlighted an success of an ETV in communicating hydrocephalus as well. Thus, the aim of the present study is to compare ventriculo-peritoneal shunting against ETV in patients with an idiopathic normal pressure hydrocephalus, an subset of communicating hydrocephalus, in a randomized, controlled multicenter study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Pressure Hydrocephalus
Keywords
endoscopic third ventriculostomy, ventricular peritoneal shunt, communicating hydrocephalus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
endoscopic third ventriculostomy
Arm Type
Experimental
Arm Description
endoscopic third ventriculostomy for the treatment of iNPH
Arm Title
ventricular peritoneal shunt
Arm Type
Active Comparator
Arm Description
Insertion of a ventriculo-peritoneal Shunt for the treatment of iNPH
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Third Ventriculostomy
Intervention Description
patients receive an endoscopic third ventriculotomy as surgical procedure
Intervention Type
Procedure
Intervention Name(s)
Ventriculo-Peritoneal Shunting
Intervention Description
patients receive an ventriculo-peritoneal shunt as surgical procedure
Primary Outcome Measure Information:
Title
Kiefer Index
Description
Improvment of at least 2 points
Time Frame
1 year
Title
Recovery Index
Description
Improvment of at least 2 points
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 50 years
gait disturbances typical for iNPH
symptoms Duration less than 36months
exclusion of obstructive hydrocephalus
positive spinal TAP-test
Exclusion Criteria:
no informed consent
malignant disease
other diseases of the CNS (Parkinson, dementia)
secondary communicating hydrocephalus
Facility Information:
Facility Name
University Medicine Greifswald
City
Greifswald
ZIP/Postal Code
17489
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sascha Marx, MD
Phone
00493834866163
Email
marxs@uni-greifswald.de
First Name & Middle Initial & Last Name & Degree
Henry WS Schroeder, MD, PhD
Phone
00493834866163
Email
henry.schroeder@uni-greifswald.de
Facility Name
University Medicine Göttingen
City
Göttingen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingo Fiss, MD
Email
ingo.fiss@med.uni-goettingen.de
First Name & Middle Initial & Last Name & Degree
Veit Rohde, MD, PhD
Email
veit.rohde@med.uni-goettingen.de
Facility Name
Klinikum Neubrandenburg
City
Neubrandenburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksandra Smilgrin, MD
Email
smilgina@dbknb.de
First Name & Middle Initial & Last Name & Degree
Michael Fritsch, MD, PhD
Email
fritschm@dbknb.de
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus
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