Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors
19 Years
N/A
Both
Primary Brain Tumor, Metastatic Brain Tumor
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.
Pre-operative:
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
work-up.
Intra-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.
Post-operative:
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
follow-up.
Inclusion Criteria:
1. Patients 19 years and older.
2. Brain tumor in or near eloquent brain regions that is appropriate for attempted
resection.
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
themselves.
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:
Observational
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:
No
Principal Investigator
Michele Aizenberg, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Nebraska
Authority:
United States: Institutional Review Board
Study ID:
671-11-FB
NCT ID:
NCT01535430
Start Date:
January 2012
Completion Date:
December 2015
Related Keywords:
- Primary Brain Tumor
- Metastatic Brain Tumor
- brain mapping
- brain tumor
- Brain Neoplasms
Name | Location |
|---|---|
| University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
