Patients Operated on at the Neurosurgery DepartmentnphysdocuNCT01630785
Neurophysiological Intraoperative or Epilepsy Monitoring
An observational study of Patients Operated on at the Neurosurgery Department, run by University of Zurich at 1 site in Switzerland.
Trial summary
The investigators record the outcome of patients whose surgery involved intraoperative neurophysiological monitoring Trial with surgical intervention Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Patients Operated on at the Neurosurgery Department
- What is being tested?
- Intraoperative Neurophysiological Monitoring IONM
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Dec 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients whose surgery involved intraoperative neurophysiological monitoring
Inclusion criteria: Patients whose surgery involved intraoperative neurophysiological monitoring
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University Hospital Zurich, Neurosurgery
Zurich, Canton of Zurich, 8091
About this study
Official title: 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
- Being tested
- Intraoperative Neurophysiological Monitoring IONM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Neurophysiological Monitoring IONMDevice
Intraoperative Neurophysiological Monitoring IONM device. Manufacturer: Inomed, Emmendingen, Germany
| Study group | Role | What they receive |
|---|---|---|
| IONM patients | all patients where surgery requires IONM Receives: Device: Intraoperative Neurophysiological Monitoring IONM |
What is being measured
The primary outcome is the main question the study is designed to answer.
oncological outcome
overall survival, progression free survival
Measured: 5 years
neurological outcome
validated scales like Karnofsky or NIHSS
Measured: 1 year
seizure outcome
ILAE classification of epilepsy surgery outcome
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Operated on at the Neurosurgery DepartmentStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Sarnthein, Prof Dr, Principal investigator, University Hospital Zurich, Division of NeurosurgeryOliver Bozinov, PD Dr, Principal investigator, University Hospital Zurich, Division of NeurosurgeryNiklaus Krayenbühl, Prof Dr, Principal investigator, University Hospital Zurich, Division of NeurosurgeryLuca Regli, Prof Dr, Principal investigator, University Hospital Zurich, Division of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630785
- Sponsor's protocol ID
- nphysdocu
- Acronym
- nphysdocu
- Status last verified
- Jan 2026
- First submitted
- 21 Jun 2012
- Last updated
- 26 Oct 2026
- Results posted
- No
Publications
Yang Y, Neidert MC, Velz J, Kalin V, Sarnthein J, Regli L, Bozinov O. Mapping and Monitoring of the Corticospinal Tract by Direct Brainstem Stimulation. Neurosurgery. 2022 Sep 1;91(3):496-504. doi: 10.1227/neu.0000000000002065. Epub 2022 Jul 14.
PubMed 35876678
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Data Analysis of Neurophysiological Data for Intraoperative or Epilepsy Monitoring
- ClinicalTrials.gov ID
- NCT01630785
- Acronym / sponsor ID
- nphysdocu / nphysdocu
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators record the outcome of patients whose surgery involved intraoperative neurophysiological monitoring
- Trial with surgical intervention
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IONM patients | – | Device: Intraoperative Neurophysiological Monitoring IONMall patients where surgery requires IONM |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients whose surgery involved intraoperative neurophysiological monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Neurophysiological Monitoring IONMIntraoperative Neurophysiological Monitoring IONM device. Manufacturer: Inomed, Emmendingen, Germany | Device | IONM patients |
Primary outcome
oncological outcome
Time frame: 5 years
overall survival, progression free survival
neurological outcome
Time frame: 1 year
validated scales like Karnofsky or NIHSS
seizure outcome
Time frame: 1 year
ILAE classification of epilepsy surgery outcome
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Derived from this study: PubMed 35876678Yang Y, Neidert MC, Velz J, Kalin V, Sarnthein J, Regli L, Bozinov O. Mapping and Monitoring of the Corticospinal Tract by Direct Brainstem Stimulation. Neurosurgery. 2022 Sep 1;91(3):496-504. doi: 10.1227/neu.0000000000002065. Epub 2022 Jul 14.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johannes Sarnthein, Prof Dr principal investigator
University Hospital Zurich, Division of Neurosurgery
Oliver Bozinov, PD Dr principal investigator
University Hospital Zurich, Division of Neurosurgery
Niklaus Krayenbühl, Prof Dr principal investigator
University Hospital Zurich, Division of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Operated on at the Neurosurgery Department, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oncological outcome (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01630785, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.