- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01630785
Neurophysiological Intraoperative or Epilepsy Monitoring (nphysdocu)
November 30, 2023 updated by: University of Zurich
Retrospective Data Analysis of Neurophysiological Data for Intraoperative or Epilepsy Monitoring
The investigators record the outcome of patients whose surgery involved intraoperative neurophysiological monitoring
- Trial with surgical intervention
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
5000
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
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Neurosurgery
-
-
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
1 year to 98 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All patients whose surgery involved intraoperative neurophysiological monitoring
Description
Inclusion criteria: Patients whose surgery involved intraoperative neurophysiological monitoring
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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
IONM patients
all patients where surgery requires IONM
|
Intraoperative Neurophysiological Monitoring IONM device.
Manufacturer: Inomed, Emmendingen, Germany
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
oncological outcome
Time Frame: 5 years
|
overall survival, progression free survival
|
5 years
|
neurological outcome
Time Frame: 1 year
|
validated scales like Karnofsky or NIHSS
|
1 year
|
seizure outcome
Time Frame: 1 year
|
ILAE classification of epilepsy surgery outcome
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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: Luca Regli, Prof Dr, University Hospital Zurich, Division of Neurosurgery
- Principal Investigator: Niklaus Krayenbühl, Prof Dr, University Hospital Zurich, Division of Neurosurgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2012
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
June 21, 2012
First Submitted That Met QC Criteria
June 26, 2012
First Posted (Estimated)
June 28, 2012
Study Record Updates
Last Update Posted (Estimated)
December 1, 2023
Last Update Submitted That Met QC Criteria
November 30, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- nphysdocu
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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