- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02402075
Spinal Motor Evoked Potentials in Brain Surgery
March 27, 2015 updated by: Andrea Szelenyi, Heinrich-Heine University, Duesseldorf
Spinal Motor Evoked Potentials During Neurosurgical Procedures Within the Central Region
During neurosurgical resection of brain tumors within brain areas for motor control, it is important to monitor motor function.
For this muscle motor evoked potentials are used.
Those are elicited by transcranial and direct cortical stimulation.
Motor responses are recorded from muscles.
In neurosurgical procedures for spinal cord tumors, the same methods are used, but additionally motor activity is recorded from the spinal cord.
This is called spinal motor evoked potentials.
It is known that the relation between spinal and muscle motor evoked potentials helps to extent the resection of spinal cord tumors.
This study implements the spinal motor evoked potential into brain tumor surgery and analyses the relationship between spinal and muscle motor evoked potentials.
With this, detection of injury to the brain area for motor control might be discovered earlier and thus tumor resection can be performed safely.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrea Szelenyi, MD PhD
- Phone Number: +492118117646
- Email: andrea.szelenyi@uni-duesseldorf.de
Study Locations
-
-
-
Duesseldorf, Germany, 40225
- Recruiting
- Neurosurgical Department
-
Contact:
- Michael Sabel, MD PhD
- Phone Number: 16276 +4921181
- Email: Michael.Sabel@med.uni-duesseldorf.de
-
Sub-Investigator:
- Jan Vesper, MD PhD
-
Sub-Investigator:
- Stefan Schu, MD
-
Sub-Investigator:
- Michael Sabel, MD PhD
-
Frankfurt, Germany, 60528
- Recruiting
- Department of Neurosurgery
-
Contact:
- Lutz Weise, MD
- Phone Number: 5989 +49696301
- Email: lutz.weise@med.uni-frankfurt.de
-
Principal Investigator:
- Lutz Weise, MD
-
-
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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with glioma
Description
Inclusion Criteria:
- > 18 years
- tumor location adjacent to the motor cortex and corticospinal tract
Exclusion Criteria:
- minor
- neurological degenerative diseases
- neurological immunological diseases
- drug abuse
- implanted medical devices such as cardiac pacemaker
- spine deformation
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
Cohorts and Interventions
Group / Cohort |
---|
Brain tumor
patients with glioma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
D-wave measurement
Time Frame: 24 hours
|
numeric assessment, amplitude and latency of D-wave
|
24 hours
|
Clinical motor status according to the MRC scheme
Time Frame: 6 months
|
clinical motor status according to the MRC scheme
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Andrea Szelenyi, MD PhD, Neurosurgical Department, Heinrich Heine University
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, 2014
Primary Completion (ANTICIPATED)
December 1, 2015
Study Completion (ANTICIPATED)
December 1, 2015
Study Registration Dates
First Submitted
March 17, 2015
First Submitted That Met QC Criteria
March 27, 2015
First Posted (ESTIMATE)
March 30, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
March 30, 2015
Last Update Submitted That Met QC Criteria
March 27, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASze_DF_001
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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