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.|
|ClinicalTrials.gov Identifier: NCT01535430|
Recruitment Status : Recruiting
First Posted : February 17, 2012
Last Update Posted : June 5, 2019
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|
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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||June 2021|
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01535430
|Contact: Michele Aizenberg, MDfirstname.lastname@example.org|
|Contact: Brandon Reicks, PA-Cemail@example.com|
|United States, Nebraska|
|University of Nebraska Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68198|
|Contact: Michele Aizenberg, MD 402-559-9614 firstname.lastname@example.org|
|Contact: Brandon Reicks, PA-C 402-559-9603 email@example.com|
|Principal Investigator: Michele Aizenberg, MD|
|Principal Investigator:||Michele Aizenberg, MD||University of Nebraska|