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Neurophysiological Intraoperative or Epilepsy Monitoring (nphysdocu)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01630785
Recruitment Status : Enrolling by invitation
First Posted : June 28, 2012
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:

The investigators record the outcome of patients whose surgery involved intraoperative neurophysiological monitoring

  • Trial with surgical intervention

Condition or disease Intervention/treatment
Patients Operated on at the Neurosurgery Department Device: Intraoperative Neurophysiological Monitoring IONM

Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Retrospective Data Analysis of Neurophysiological Data for Intraoperative or Epilepsy Monitoring
Study Start Date : January 2012
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Groups and Cohorts
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Group/Cohort Intervention/treatment
IONM patients
all patients where surgery requires IONM
 Device: Intraoperative Neurophysiological Monitoring IONM
Intraoperative Neurophysiological Monitoring IONM device. Manufacturer: Inomed, Emmendingen, Germany


Outcome Measures
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Primary Outcome Measures :
  1. oncological outcome [ Time Frame: 5 years ]
    overall survival, progression free survival

  2. neurological outcome [ Time Frame: 1 year ]
    validated scales like Karnofsky or NIHSS

  3. seizure outcome [ Time Frame: 1 year ]
    ILAE classification of epilepsy surgery outcome


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients whose surgery involved intraoperative neurophysiological monitoring
Criteria
Inclusion criteria: Patients whose surgery involved intraoperative neurophysiological monitoring
Contacts and Locations
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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): NCT01630785


Locations
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Switzerland
University Hospital Zurich, Neurosurgery
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Johannes Sarnthein, Prof Dr University Hospital Zurich, Division of Neurosurgery
Principal Investigator: Oliver Bozinov, PD Dr University Hospital Zurich, Division of Neurosurgery
Principal Investigator: Niklaus Krayenbühl, Prof Dr University Hospital Zurich, Division of Neurosurgery
Principal Investigator: Luca Regli, Prof Dr University Hospital Zurich, Division of Neurosurgery
More Information
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01630785    
Other Study ID Numbers: nphysdocu
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases