Assessment of Eloquent Function in Brain Tumor Patients

NCT01535430 | Recruiting FDA Device

• 2 other identifiers: 0240-24-FB0671-11-FB
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Brain Tumor; Metastatic Brain Tumor

Keywords

brain mapping; brain tumor

Outcome Measures

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.

  1 year

Study Arms (1)

Eloquent area tumor

Standard of care with brain mapping, pre-, intra-, and post-operative.

Diagnostic Test: Brain mapping

Interventions

Brain mapping DIAGNOSTIC_TEST

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

Eloquent area tumor

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with a brain tumor in or near an area of eloquent brain function (speech, motor, sensory).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 32006951 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Brain Mapping

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Functional Neuroimaging; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Michele Aizenberg, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dulce Maroni, PhD

CONTACT

402-836-9751; dmaroni@unmc.edu

Katie Maire, MS

CONTACT

402-559-6895; kmaire@unmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 17, 2012
• Study Start: January 31, 2012
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)