Skip to main content
OpenTrials
Recruiting

NCT Number: NCT01535430

Assessment of Eloquent Function in Brain Tumor Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain mapping

Diagnostic Test

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

Primary outcomes

  1. 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 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dulce Maroni, PhD

CONTACT

[email protected]

402-836-9751

Katie Maire, MS

CONTACT

[email protected]

402-559-6895

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2026
Study completion
2027
First posted
Feb 17, 2012
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.