Spinal Motor Evoked Potentials in Brain Surgery

Glioma Clinical Trial

Official title:

Spinal Motor Evoked Potentials During Neurosurgical Procedures Within the Central Region

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02402075
• Other study ID #: ASze_DF_001
• Status: Recruiting
• Phase: N/A
• First received: March 17, 2015
• Last updated: March 27, 2015
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Andrea Szelenyi, MD PhD
• Phone: +492118117646
• Email: andrea.szelenyi[@]uni-duesseldorf.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Glioma

Locations

Country	Name	City	State
Germany	Neurosurgical Department	Duesseldorf
Germany	Department of Neurosurgery	Frankfurt

Sponsors (2)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf	Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	D-wave measurement	numeric assessment, amplitude and latency of D-wave	24 hours	No
Primary	Clinical motor status according to the MRC scheme	clinical motor status according to the MRC scheme	6 months	No