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Assessment of Eloquent Function in Brain Tumor Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01535430
Recruitment Status : Recruiting
First Posted : February 17, 2012
Last Update Posted : April 19, 2021
Information provided by (Responsible Party):
Michele Aizenberg, MD, University of Nebraska

Brief Summary:

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.

Condition or disease
Primary Brain Tumor Metastatic Brain Tumor

Detailed Description:

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 work-up.


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 follow-up.

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors
Study Start Date : January 2012
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Primary Outcome Measures :
  1. Eloquent function [ Time Frame: 1 year ]
    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. Addtionally, novel ways of identifying eloquent brain regions will be developed.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with a brain tumor in or near an area of eloquent brain function (speech, motor, sensory).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01535430

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Contact: Dulce Maroni, PhD 402-836-9751
Contact: Katie Maire, MS 402-559-6895

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United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Dulce Maroni, PhD    402-836-9751   
Contact: Katie Maire, MS    402-559-6895   
Principal Investigator: Michele Aizenberg, MD         
Sponsors and Collaborators
University of Nebraska
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Principal Investigator: Michele Aizenberg, MD University of Nebraska
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Michele Aizenberg, MD, Principal Investigator, University of Nebraska Identifier: NCT01535430    
Other Study ID Numbers: 671-11-FB
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Keywords provided by Michele Aizenberg, MD, University of Nebraska:
brain mapping
brain tumor
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases