Assessment of Eloquent Function in Brain Tumor Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01535430
First received: February 8, 2012
Last updated: May 31, 2013
Last verified: May 2013

February 8, 2012
May 31, 2013
January 2012
February 2015   (final data collection date for primary outcome measure)
Eloquent function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01535430 on ClinicalTrials.gov Archive Site
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Assessment of Eloquent Function in Brain Tumor Patients
Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors

Purpose of the study:

AIM 1 Prospectively collect pre-operative (fMRI, DTI, MEG) and intra-operative mapping data in patients with intra-axial brain tumors to assess how well each modality predicts the location of eloquent brain function. In addition, each modality will be compared with the other.

AIM 2 Assess reorganization of eloquent brain function and plasticity in patients with intra-axial brain tumors. This will be accomplished by prospectively collecting post-operative mapping studies and neuropsychological tests to compare them to prior mapping studies as stated above.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patient with a brain tumor in or near an area of eloquent brain function (speech, motor, sensory).

  • Primary Brain Tumor
  • Metastatic Brain Tumor
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2015
February 2015   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact: Michele Aizenberg, MD 402-559-9614 maizenberg@unmc.edu
Contact: Brandon Reicks, PA-C 402-559-9603 breicks@unmc.edu
United States
 
NCT01535430
671-11-FB
No
University of Nebraska
University of Nebraska
Not Provided
Principal Investigator: Michele Aizenberg, MD University of Nebraska
University of Nebraska
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP