Spinal Motor Evoked Potentials in Brain Surgery

NCT ID: NCT02402075

Last Updated: 2015-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Tumor Glioma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Brain tumor

patients with glioma

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Andrea Szelenyi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Szelenyi, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Neurosurgical Department, Heinrich Heine University

Locations

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Neurosurgical Department

Düsseldorf, , Germany

Site Status RECRUITING

Department of Neurosurgery

Frankfurt, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Andrea Szelenyi, MD PhD

Role: CONTACT

+492118117646

Facility Contacts

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Michael Sabel, MD PhD

Role: primary

+4921181 ext. 16276

Lutz Weise, MD

Role: primary

+49696301 ext. 5989

Other Identifiers

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ASze_DF_001

Identifier Type: -

Identifier Source: org_study_id

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