Clinical trial · Observational
Multi-modality Localization of Eloquent Brain Function
Multi-modality Localization of Eloquent Brain Function-A Comparison of Technologies for Improved Applicability
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Project did not receive funding and was never started
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brain mapping | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Location in the brain of the fMRI activations relative to intra-operative brain mapping
- timeFrame
- 5 years
- description
- 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.
- measure
- Location in the brain of the MEG activations relative to intra-operative brain mapping
- timeFrame
- 5 years
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available