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Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors

19 Years
Open (Enrolling)
Primary Brain Tumor, Metastatic Brain Tumor

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Trial Information

Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors

Any patient with a primary or metastatic brain tumor in or near an eloquent area would be
eligible for participation in the study assuming no contraindications to any of the studies
or operative procedure.


Evaluation will include clinical evaluation, neuropsychological testing, MRI brain with and
without contrast, fMRI, DTI tractograms, and MEG studies as well as standard pre-operative


All non-invasive pre-operative mapping data will be incorporated into the operative
procedure with the imaging tools that we routinely use during neurosurgical procedures.
Patients will have awake mapping performed. Our usual standards of care will be followed
during craniotomy, mapping, and tumor resection or biopsy.


Patients will have routine post-operative care and assessment consisting of clinical
examinations and imaging obtained within 24 hours post resection. They will have routine
follow-up outpatient appointments after surgery which will include neurologic assessment and
follow-up imaging (MRI with and without contrast) for their tumors as appropriate. The
experimental portion of the protocol is incorporating repeat neuropsychological testing and
mapping studies (fMRI, DTI, MEG) studies at 2 and 6 months post-surgery into their routine

Inclusion Criteria:

1. Patients 19 years and older.

2. Brain tumor in or near eloquent brain regions that is appropriate for attempted

3. Appropriate body habitus and mental status/capacity to participate with non-invasive
or invasive mapping.

4. Benign or malignant intra-axial brain tumor.

5. Primary or metastatic intra-axial brain tumor.

Exclusion Criteria:

1. Any patient with a contraindication to MRI (i.e. implanted devices)

2. Inappropriate body habitus or mental status/capacity to participate with non-invasive
or invasive mapping in a safe and reliable manner.

3. Patient declines to participate.

4. Patient that does not have the capacity to understand the study or consent for

5. Neurologic status which precludes them from testing (poor function- not testable).

6. Positive pregnancy test in females.

7. Any patient with end stage renal disease or severe renal dysfunction.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Eloquent function

Outcome Description:

The location of the eloquent function of interest (motor, sensory, speech) will be assessed pre-operatively and intra-operatively. These will be compared. Then, at 2 and 6 months post-operatively, repeat non-invasive mapping studies will be performed to compare to the subjects' prior studies. This will allow for assessment of reorganization and plasticity of function.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Michele Aizenberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska


United States: Institutional Review Board

Study ID:




Start Date:

January 2012

Completion Date:

December 2015

Related Keywords:

  • Primary Brain Tumor
  • Metastatic Brain Tumor
  • brain mapping
  • brain tumor
  • Brain Neoplasms



University of Nebraska Medical Center Omaha, Nebraska  68198-3330