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

Study Locations

      • Duesseldorf, Germany, 40225
        • Recruiting
        • Neurosurgical Department
        • Contact:
        • 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:
        • 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.

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

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.

Clinical Trials on Glioma

3
Subscribe