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Assessment of Eloquent Function in Brain Tumor Patients

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ClinicalTrials.gov Identifier: NCT01535430
Recruitment Status : Recruiting
First Posted : February 17, 2012
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Michele Aizenberg, MD, University of Nebraska

Tracking Information
First Submitted Date February 8, 2012
First Posted Date February 17, 2012
Last Update Posted Date April 19, 2021
Study Start Date January 2012
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2019)
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.
Original Primary Outcome Measures
 (submitted: February 14, 2012)
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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Eloquent Function in Brain Tumor Patients
Official Title Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors
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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient with a brain tumor in or near an area of eloquent brain function (speech, motor, sensory).
Condition
  • Primary Brain Tumor
  • Metastatic Brain Tumor
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Ellis DG, White ML, Hayasaka S, Warren DE, Wilson TW, Aizenberg MR. Accuracy analysis of fMRI and MEG activations determined by intraoperative mapping. Neurosurg Focus. 2020 Feb 1;48(2):E13. doi: 10.3171/2019.11.FOCUS19784.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 16, 2021)
75
Original Estimated Enrollment
 (submitted: February 14, 2012)
10
Estimated Study Completion Date June 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Dulce Maroni, PhD 402-836-9751 dmaroni@unmc.edu
Contact: Katie Maire, MS 402-559-6895 kmaire@unmc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01535430
Other Study ID Numbers 671-11-FB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michele Aizenberg, MD, University of Nebraska
Study Sponsor University of Nebraska
Collaborators Not Provided
Investigators
Principal Investigator: Michele Aizenberg, MD University of Nebraska
PRS Account University of Nebraska
Verification Date April 2021