Spinal Motor Evoked Potentials in Brain Surgery

NCT02402075 | Unknown

• 1 other identifier: ASze_DF_001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• D-wave measurement

  numeric assessment, amplitude and latency of D-wave

  24 hours

• Clinical motor status according to the MRC scheme

  clinical motor status according to the MRC scheme

  6 months

Study Arms (1)

Brain tumor

patients with glioma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with glioma

You may qualify if:

• \> 18 years
• tumor location adjacent to the motor cortex and corticospinal tract

You may not qualify if:

• minor
• neurological degenerative diseases
• neurological immunological diseases
• drug abuse
• implanted medical devices such as cardiac pacemaker
• spine deformation

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• Johann Wolfgang Goethe University Hospital: collaborator

Study Sites (2)

Neurosurgical Department

Düsseldorf, 40225, Germany

RECRUITING

Department of Neurosurgery

Frankfurt, 60528, Germany

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Glioma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Andrea Szelenyi, MD PhD

  Neurosurgical Department, Heinrich Heine University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Szelenyi, MD PhD

CONTACT

+492118117646; andrea.szelenyi@uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 30, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 30, 2015

Record last verified: 2015-03

Locations

DE (2)