- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03245138
Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus
November 5, 2018 updated by: Sascha Marx, University Medicine Greifswald
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Greifswald, Germany, 17489
- Recruiting
- University Medicine Greifswald
-
Contact:
- Sascha Marx, MD
- Phone Number: 00493834866163
- Email: marxs@uni-greifswald.de
-
Contact:
- Henry WS Schroeder, MD, PhD
- Phone Number: 00493834866163
- Email: henry.schroeder@uni-greifswald.de
-
Göttingen, Germany
- Not yet recruiting
- University Medicine Göttingen
-
Contact:
- Ingo Fiss, MD
- Email: ingo.fiss@med.uni-goettingen.de
-
Contact:
- Veit Rohde, MD, PhD
- Email: veit.rohde@med.uni-goettingen.de
-
Neubrandenburg, Germany
- Recruiting
- Klinikum Neubrandenburg
-
Contact:
- Aleksandra Smilgrin, MD
- Email: smilgina@dbknb.de
-
Contact:
- Michael Fritsch, MD, PhD
- Email: fritschm@dbknb.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: endoscopic third ventriculostomy
endoscopic third ventriculostomy for the treatment of iNPH
|
patients receive an endoscopic third ventriculotomy as surgical procedure
|
Active Comparator: ventricular peritoneal shunt
Insertion of a ventriculo-peritoneal Shunt for the treatment of iNPH
|
patients receive an ventriculo-peritoneal shunt as surgical procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kiefer Index
Time Frame: 1 year
|
Improvment of at least 2 points
|
1 year
|
Recovery Index
Time Frame: 1 year
|
Improvment of at least 2 points
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
July 31, 2017
First Submitted That Met QC Criteria
August 7, 2017
First Posted (Actual)
August 10, 2017
Study Record Updates
Last Update Posted (Actual)
November 6, 2018
Last Update Submitted That Met QC Criteria
November 5, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETV versus VPS in iNPH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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