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

NCT ID: NCT03245138

Last Updated: 2018-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Normal Pressure Hydrocephalus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

endoscopic third ventriculostomy

endoscopic third ventriculostomy for the treatment of iNPH

Group Type EXPERIMENTAL

Endoscopic Third Ventriculostomy

Intervention Type PROCEDURE

patients receive an endoscopic third ventriculotomy as surgical procedure

ventricular peritoneal shunt

Insertion of a ventriculo-peritoneal Shunt for the treatment of iNPH

Group Type ACTIVE_COMPARATOR

Ventriculo-Peritoneal Shunting

Intervention Type PROCEDURE

patients receive an ventriculo-peritoneal shunt as surgical procedure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endoscopic Third Ventriculostomy

patients receive an endoscopic third ventriculotomy as surgical procedure

Intervention Type PROCEDURE

Ventriculo-Peritoneal Shunting

patients receive an ventriculo-peritoneal shunt as surgical procedure

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sascha Marx

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Medicine Göttingen

Göttingen, , Germany

Site Status NOT_YET_RECRUITING

University Medicine Greifswald

Greifswald, , Germany

Site Status RECRUITING

Klinikum Neubrandenburg

Neubrandenburg, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ingo Fiss, MD

Role: primary

Veit Rohde, MD, PhD

Role: backup

Sascha Marx, MD

Role: primary

00493834866163

Henry WS Schroeder, MD, PhD

Role: backup

00493834866163

Aleksandra Smilgrin, MD

Role: primary

Michael Fritsch, MD, PhD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ETV versus VPS in iNPH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The CSF Shunt Entry Site Trial
NCT02425761 UNKNOWN PHASE3