Brain TumorNCT02402075
Spinal Motor Evoked Potentials in Brain Surgery
An observational study of Brain Tumor and Glioma, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Glioma
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with glioma
Who may be able to join
- > 18 years
- tumor location adjacent to the motor cortex and corticospinal tract
Who cannot join
- minor
- neurological degenerative diseases
- neurological immunological diseases
- drug abuse
- implanted medical devices such as cardiac pacemaker
- spine deformation
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Neurosurgical Department
Düsseldorf, 40225
Michael Sabel, MD PhD, +4921181 ext. 16276, Michael.Sabel@med.uni-duesseldorf.de
Jan Vesper, MD PhD
- Recruiting
Department of Neurosurgery
Frankfurt, 60528
Lutz Weise, MD, +49696301 ext. 5989, lutz.weise@med.uni-frankfurt.de
Lutz Weise, MD
About this study
Official title: 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.
- Conditions
- Brain Tumor, Glioma
- Keywords
- muscle motor evoked potentials, spinal motor evoked potentials, D-wave, brain tumor surgery, intraoperative neuromonitoring
- Medical subject headings
- Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Brain tumor | patients with glioma |
What is being measured
The primary outcome is the main question the study is designed to answer.
D-wave measurement
numeric assessment, amplitude and latency of D-wave
Measured: 24 hours
Clinical motor status according to the MRC scheme
clinical motor status according to the MRC scheme
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- Johann Wolfgang Goethe University Hospital
- Responsible party
- Principal investigator, Andrea Szelenyi, Heinrich-Heine University, Duesseldorf
- Investigators
- Andrea Szelenyi, MD PhD, Principal investigator, Neurosurgical Department, Heinrich Heine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402075
- Sponsor's protocol ID
- ASze_DF_001
- Status last verified
- Mar 2015
- First submitted
- 17 Mar 2015
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Motor Evoked Potentials During Neurosurgical Procedures Within the Central Region
- ClinicalTrials.gov ID
- NCT02402075
- Acronym / sponsor ID
- ASze_DF_001
- Conditions
- Brain Tumor, Glioma
- Keywords
- muscle motor evoked potentials, spinal motor evoked potentials, D-wave, brain tumor surgery, intraoperative neuromonitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- Johann Wolfgang Goethe University Hospital
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Mar 2015 (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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain tumor | – | –patients with glioma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with glioma
Key inclusion criteria (2 listed)
- > 18 years
- tumor location adjacent to the motor cortex and corticospinal tract
Key exclusion criteria (6 listed)
- minor
- neurological degenerative diseases
- neurological immunological diseases
- drug abuse
- implanted medical devices such as cardiac pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
D-wave measurement
Time frame: 24 hours
numeric assessment, amplitude and latency of D-wave
Clinical motor status according to the MRC scheme
Time frame: 6 months
clinical motor status according to the MRC scheme
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
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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. This study is not recruiting at the moment.
Andrea Szelenyi, MD PhD principal investigator
Neurosurgical Department, Heinrich Heine University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Glioma, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Szelenyi, MD PhD (+492118117646, andrea.szelenyi@uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
D-wave measurement (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2015.