Assessing brain function in patients with brain tumors
Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors
This study is testing different brain imaging techniques to see how well they can help doctors understand brain function in patients with brain tumors before and after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Nebraska Academic / other |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT01535430 on ClinicalTrials.gov |
What this trial studies
This study aims to collect and analyze various imaging data, including functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), and magnetoencephalography (MEG), from patients with primary or metastatic brain tumors located near eloquent brain areas. The research will evaluate how well these imaging modalities predict the location of critical brain functions before surgery and assess changes in brain function and plasticity after tumor removal. Participants will undergo a series of pre-operative evaluations, intra-operative mapping, and post-operative assessments to monitor their neurological status and recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with a brain tumor located in or near eloquent brain regions suitable for surgical resection.
Not a fit: Patients with contraindications to MRI or those with severe neurological impairments that prevent testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes by improving the accuracy of brain mapping techniques, leading to better preservation of critical brain functions.
How similar studies have performed: Other studies utilizing advanced brain mapping techniques have shown promise in improving surgical outcomes, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Omaha, Nebraska
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Principal investigator: Michele Aizenberg, MD — University of Nebraska
- Study coordinator: Dulce Maroni, PhD
- Email: dmaroni@unmc.edu
- Phone: 402-836-9751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.