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
  Purpose

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
Primary Brain Tumor
Metastatic Brain Tumor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 10
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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).

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535430

Contacts
Contact: Michele Aizenberg, MD 402-559-9614 maizenberg@unmc.edu
Contact: Brandon Reicks, PA-C 402-559-9603 breicks@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Michele Aizenberg, MD    402-559-9614    maizenberg@unmc.edu   
Contact: Brandon Reicks, PA-C    402-559-9603    breicks@unmc.edu   
Principal Investigator: Michele Aizenberg, MD         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Michele Aizenberg, MD University of Nebraska
  More Information

No publications provided

Responsible Party: University of Nebraska
ClinicalTrials.gov Identifier: NCT01535430     History of Changes
Other Study ID Numbers: 671-11-FB
Study First Received: February 8, 2012
Last Updated: May 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
brain mapping
brain tumor

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 26, 2014