Assessment of Eloquent Function in Brain Tumor Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorUniversity of Nebraska
About this trial
Purpose of the study:
AIM 1: Prospectively collect pre-operative \[functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), magnetoencephalography (MEG)\] 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
19 years and older
Brain tumor in or near eloquent brain regions that is appropriate for attempted resection
Appropriate body habitus and mental status/capacity to participate with non-invasive or invasive mapping
Benign or malignant intra-axial brain tumor
Disqualifiers
Any contraindication to MRI (i.e. implanted devices)
Inappropriate body habitus or mental status/capacity to participate with non-invasive or invasive mapping in a safe and reliable manner
Declining to participate
Lacks capacity to understand the study or consent for themselves
Trial population
Patient with a brain tumor in or near an area of eloquent brain function (speech, motor, sensory).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Brain mapping
Diagnostic testBrain mapping will be employed pre-, intra-, and post-operatively to evaluate specific functions.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Eloquent area tumor1 intervention
Trial outcomes
Primary outcomes
1
Eloquent function
The location of the eloquent function of interest (motor, sensory, speech) will be assessed pre-operatively and intra-operatively and 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. Additionally, novel ways of identifying eloquent brain regions will be developed.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov