Multi-modality Localization of Eloquent Brain Function

NCT02795338 | Withdrawn

• 1 other identifier: 0176-16-EP
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Accurate identification of areas of eloquent brain function is vital to surgical decision making and to preservation of independence as patients with brain tumors who are higher functioning have better survival outcomes. Eloquent brain is defined as a region controlling language, motor, or sensory function such that without its proper input, a person would be left with significant neurologic deficits. Imaging technology has evolved to provide multiple non-invasive modalities for pre-operative testing of eloquent brain function. Studies have shown that these non-invasive mapping modalities provide useful information, however, the information provided inconsistently predicts distribution of eloquent function. Direct electrical stimulation (DES) at surgery allows assessment of eloquent function directly from the brain surface (invasive) and is considered the gold standard in brain mapping. Therefore, in order to determine the true clinical applicability of the non-invasive mapping technologies, this study proposes to assess the predictive value of functional MRI (fMRI) and magnetoencephalography (MEG) for sensorimotor and language functions by comparing results to DES and determine whether fMRI or MEG provides the most consistent and accurate information. The rationale for the proposed research is that understanding the reliability of our current technology will allow us to perform safer surgeries and to preserve neurologic function.

Conditions

Brain Neoplasms

Outcome Measures

Primary Outcomes (3)

• Location in the brain of the fMRI activations relative to intra-operative brain mapping

  Assess the predictive value of fMRI for language and sensorimotor function by evaluating the location in the brain where the activity was found. The pre-operative locations will be compared to the intra-operative locations which are considered the gold standard. If the fMRI activations indicate the same gyrus/gyri as the intra-operative mapping, it is considered accurate. This is accomplished with special techniques integrating multiple data time points and types.

  5 years

• Location in the brain of the MEG activations relative to intra-operative brain mapping

  Assess the predictive value of MEG for language and sensorimotor function by evaluating the location in the brain where the activity was found. The pre-operative locations will be compared to the intra-operative locations which are considered the gold standard. If the MEG activations indicate the same gyrus/gyri as the intra-operative mapping, it is considered accurate. This is accomplished with special techniques integrating multiple data time points and types.

  5 years

• Accuracy of fMRI and MEG in pre-operative brain mapping

  Assess which mapping method provides the most consistent and accurate information in pre-operative mapping for language and sensorimotor function. Determination of the testing method that most often identifies the correct anatomic location of the eloquent function as dictated by the findings from outcomes 1 and 2.

  5 years

Interventions

brain mapping PROCEDURE

pre-operative and intra-operative brain mapping to identify eloquent areas

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We propose enrolling 80 patients with brain tumors in or near eloquent brain regions who are appropriate candidates for surgery.

You may qualify if:

• informed consent
• age equal to or greater than 19 years
• gender: male and female included
• brain tumor in or near an eloquent area of the brain that requires surgery
• benign or malignant intra-axial brain tumor
• primary or secondary intra-axial brain tumor
• appropriate body habitus for operating room positioning and airway protection for awake mapping
• appropriate mental status and capacity to participate with invasive or non-invasive mapping

You may not qualify if:

• any contraindication to MRI (i.e. implanted devices)
• inappropriate body habitus for safe positioning or airway protection
• no capacity to understand the study the study or consent to it
• significant disability precluding successful mapping
• positive pregnancy test in females
• end stage renal disease or severe renal dysfunction
• sleep apnea or any obstructive airway disease
• severe anxiety disorder
• metabolic encephalopathy

Sponsors & Collaborators

• University of Nebraska: lead

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 R Aizenberg Ansari, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 10, 2016
• Study Start: February 27, 2018
• Primary Completion: February 27, 2018
• Study Completion: February 27, 2018
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share