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Trial record 2 of 28 for:    Recruiting, Not yet recruiting, Available Studies | "Hydrocephalus"

Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus

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ClinicalTrials.gov Identifier: NCT03245138
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Sascha Marx, University Medicine Greifswald

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.

Condition or disease Intervention/treatment Phase
Normal Pressure Hydrocephalus Procedure: Endoscopic Third Ventriculostomy Procedure: Ventriculo-Peritoneal Shunting Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus
Actual Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: endoscopic third ventriculostomy
endoscopic third ventriculostomy for the treatment of iNPH
Procedure: Endoscopic Third Ventriculostomy
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
Procedure: Ventriculo-Peritoneal Shunting
patients receive an ventriculo-peritoneal shunt as surgical procedure




Primary Outcome Measures :
  1. Kiefer Index [ Time Frame: 1 year ]
    Improvment of at least 2 points

  2. Recovery Index [ Time Frame: 1 year ]
    Improvment of at least 2 points



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245138


Locations
Germany
University Medicine Greifswald Recruiting
Greifswald, Germany, 17489
Contact: Sascha Marx, MD    00493834866163    marxs@uni-greifswald.de   
Contact: Henry WS Schroeder, MD, PhD    00493834866163    henry.schroeder@uni-greifswald.de   
University Medicine Göttingen Not yet recruiting
Göttingen, Germany
Contact: Ingo Fiss, MD       ingo.fiss@med.uni-goettingen.de   
Contact: Veit Rohde, MD, PhD       veit.rohde@med.uni-goettingen.de   
Klinikum Neubrandenburg Recruiting
Neubrandenburg, Germany
Contact: Aleksandra Smilgrin, MD       smilgina@dbknb.de   
Contact: Michael Fritsch, MD, PhD       fritschm@dbknb.de   
Sponsors and Collaborators
University Medicine Greifswald

Responsible Party: Sascha Marx, Principal Investigator, University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT03245138     History of Changes
Other Study ID Numbers: ETV versus VPS in iNPH
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sascha Marx, University Medicine Greifswald:
endoscopic third ventriculostomy
ventricular peritoneal shunt
communicating hydrocephalus

Additional relevant MeSH terms:
Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases