NCT03245138

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

2.5 years

First QC Date

July 31, 2017

Last Update Submit

November 5, 2018

Conditions

Normal Pressure Hydrocephalus

Keywords

endoscopic third ventriculostomyventricular peritoneal shuntcommunicating hydrocephalus

Outcome Measures

Primary Outcomes (2)

  • Kiefer Index

    Improvment of at least 2 points

    1 year

  • Recovery Index

    Improvment of at least 2 points

    1 year

Study Arms (2)

endoscopic third ventriculostomy

EXPERIMENTAL

endoscopic third ventriculostomy for the treatment of iNPH

Procedure: Endoscopic Third Ventriculostomy

ventricular peritoneal shunt

ACTIVE COMPARATOR

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

Procedure: Ventriculo-Peritoneal Shunting

Interventions

Endoscopic Third VentriculostomyPROCEDURE

patients receive an endoscopic third ventriculotomy as surgical procedure

endoscopic third ventriculostomy
Ventriculo-Peritoneal ShuntingPROCEDURE

patients receive an ventriculo-peritoneal shunt as surgical procedure

ventricular peritoneal shunt

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 50 years
  • gait disturbances typical for iNPH
  • symptoms Duration less than 36months
  • positive spinal TAP-test

You may not qualify if:

  • no informed consent
  • malignant disease
  • other diseases of the CNS (Parkinson, dementia)
  • secondary communicating hydrocephalus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Medicine Göttingen

Göttingen, Germany

NOT YET RECRUITING

University Medicine Greifswald

Greifswald, 17489, Germany

RECRUITING

Klinikum Neubrandenburg

Neubrandenburg, Germany

RECRUITING

MeSH Terms

Conditions

Hydrocephalus, Normal PressureHydrocephalus

Interventions

Ventriculostomy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Cerebrospinal Fluid ShuntsAnastomosis, SurgicalSurgical Procedures, OperativeNeurosurgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 10, 2017

Study Start

June 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2020

Last Updated

November 6, 2018

Record last verified: 2018-11

Locations

DE(3)