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Assessment of Eloquent Function in Brain Tumor Patients

Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01535430
Enrollment
75
Registered
2012-02-17
Start date
2012-01-31
Completion date
2027-12-31
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Brain Tumor, Primary Brain Tumor

Keywords

brain mapping, brain tumor

Brief summary

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.

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, magnetic resonance imaging (MRI) brain with and without contrast, fMRI, DTI tractograms, and MEG studies as well as standard pre-operative work-up. Intra-operative procedures include all non-invasive pre-operative mapping data being incorporated into the operative procedure with imaging tools that are routinely used during neurosurgical procedures. Participants will have awake mapping performed. Usual standards of care will be followed during craniotomy, mapping, and tumor resection or biopsy. Post-operative procedures include routine post-operative care and assessment consisting of clinical examinations and imaging obtained within 24 hours post-resection. Participants 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.

Interventions

DIAGNOSTIC_TESTBrain mapping

Brain mapping will be employed pre-, intra-, and post-operatively to evaluate specific functions.

Sponsors

University of Nebraska
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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 * Primary or metastatic intra-axial brain tumor

Exclusion criteria

* 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 * Neurologic status which precludes testing (poor function- not testable) * Positive pregnancy test * End stage renal disease or severe renal dysfunction

Design outcomes

Primary

MeasureTime frameDescription
Eloquent function1 yearThe 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.

Countries

United States

Contacts

Primary ContactDulce Maroni, PhD
dmaroni@unmc.edu402-836-9751
Backup ContactKatie Maire, MS
kmaire@unmc.edu402-559-6895

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026