Electrocorticography for Brain Tumor

Overseen By Sujit Prabhu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Neurological motor deficits, Speech deficits, Impaired vision, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well electrocorticography (ECoG) can map important brain areas during surgery for patients with brain tumors. The researchers aim to use a larger or more detailed grid than usual to help doctors pinpoint brain areas that control movement and speech. This could improve surgery outcomes by preserving these critical functions. The trial seeks participants undergoing tumor removal surgery at the University of Texas M. D. Anderson Cancer Center who have brain tumors near movement or speech areas. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance surgical precision and patient outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that electrocorticography is safe for brain tumor surgery?

Research has shown that electrocorticography, a technique used to map brain function during surgery, is well-tolerated by patients. Studies have found that it reduces the risk of seizures by identifying specific brain activity, aiding in the accurate mapping of areas responsible for language and movement. This enhances the safety of procedures for patients undergoing brain tumor removal.

A systematic review found direct electrocortical stimulation, which involves sending small electrical currents to the brain to pinpoint important areas, to be a highly trusted method for brain mapping. This method is widely used because it effectively helps surgeons identify critical brain regions, reducing the risk of damage during surgery.

Both techniques have been used in brain surgeries with positive safety records. While electrocorticography effectively maps functional areas, direct stimulation provides detailed information about how different parts of the brain connect. Together, they help ensure the protection of important brain areas during tumor removal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of electrocorticography (ECoG) for brain tumors because it offers a real-time, high-resolution map of brain activity during surgery. Unlike traditional imaging methods, ECoG uses grids placed directly on the brain surface, providing detailed insights into tumor boundaries and critical brain functions. This approach can potentially enhance surgical precision, reducing the risk of damaging healthy brain tissue and improving patient outcomes. Additionally, direct electrocortical stimulation allows surgeons to test brain regions in real-time, ensuring critical areas are preserved, which is a significant advancement over standard pre-surgical imaging techniques.

What evidence suggests that electrocorticography is effective for brain tumor surgery?

In this trial, participants will undergo tumor resection using electrocorticography (ECoG) as a diagnostic tool. Studies have shown that ECoG effectively maps brain activity during surgery. This technique helps surgeons distinguish between tumor and healthy tissue, which is crucial for brain tumor surgeries. ECoG is particularly useful for identifying areas involved in speech and movement, reducing the risk of affecting important brain functions. Research indicates that it also helps locate seizure activity, improving surgical outcomes for patients with epilepsy related to brain tumors. Additionally, direct electrocortical stimulation, another method used in this trial, reliably identifies critical brain regions during surgery, ensuring the safe removal of tumors. Together, these methods enhance the precision of brain surgeries, leading to better results for patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Sujit S. Prabhu

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with new or recurring primary or metastatic brain tumors near motor/speech areas, who are undergoing tumor resection at the University of Texas M. D. Anderson Cancer Center. Participants must be able to perform tasks during awake surgery and have signed consent. Those with significant upper limb or speech deficits, impaired vision/hearing affecting study participation are excluded.

Inclusion Criteria

I am having surgery at M.D. Anderson for a brain tumor near speech or motor areas.

Signed informed consent

Exclusion Criteria

Patients with significant neurological motor deficits of the upper extremities, and/or speech deficits, which would preclude them from performing the while awake intra-operative tasks at the discretion of the principal investigator (PI)

Patients who have impaired vision and/or hearing and whose performance could affect the study will be excluded at the discretion of the PI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Intraoperative Mapping

Patients undergo tumor resection and electrocorticography with high-resolution grids followed by direct electrocortical stimulation

1 day

1 visit (in-person)

Immediate Follow-up

Patients are monitored for new neurological and language/speech deficits within 24 hours post-surgery

24 hours

1 visit (in-person)

Long-term Follow-up

Participants are monitored for safety and effectiveness at 1, 3, and 6 months post-surgery

Up to 6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Direct Electrocortical Stimulation
• Electrocorticography

Trial Overview The trial tests electrocorticography (ECoG) using a standard or high-definition grid to map active brain regions during surgery in patients with brain tumors. It aims to improve identification of functional areas related to limb movement and speech.

How Is the Trial Designed?

Group I: Diagnostic (electrocorticography) Experimental Treatment 2 Interventions

Patients undergo tumor resection. During surgery, patients also undergo electrocorticography with either the CorTec high resolution hybrid grid, the PMT high-resolution grid, or the Ad-Tech grid followed by direct electrocortical stimulation.

Direct Electrocortical Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Electrocorticography for:

• Brain tumor surgery
• Epilepsy surgery
• Functional brain mapping

Approved in European Union as Electrocorticography for:

• Brain tumor surgery
• Epilepsy surgery
• Functional brain mapping

Approved in Canada as Electrocorticography for:

• Brain tumor surgery
• Epilepsy surgery
• Functional brain mapping

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Houston

Collaborator

Trials

155

Recruited

48,600+

Published Research Related to This Trial

Intraoperative electrocorticography (ECoG) is an effective technique for identifying epileptogenic areas during brain tumor surgery, leading to improved surgical outcomes for patients with tumor-related epilepsy, as shown in a review of 13 studies involving 569 patients.

The surgical treatment outcomes, measured by Engel I classification, varied significantly, with success rates ranging from 56.5% to 100%, indicating that ECoG can enhance the prognosis of epilepsy surgery, although more large-scale randomized controlled trials are needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The utility of intraoperative ECoG in tumor-related epilepsy: Systematic review. Zhu, Q., Liang, Y., Fan, Z., et al.[2022]

In a study of 138 patients undergoing awake craniotomy, early postoperative seizures (EPS) occurred in 11.3% of cases, with significant risk factors identified including acute abnormalities on neuroimaging, young age, and persistent neurological deficits.

The findings suggest that monitoring for EPS should be prioritized in patients with these risk factors, as EPS is associated with worse short-term outcomes, highlighting the importance of adjusting perioperative antiseizure medication accordingly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Postoperative Seizures Following Awake Craniotomy and Functional Brain Mapping for Lesionectomy. Freund, BE., Feyissa, AM., Khan, A., et al.[2023]

Intraoperative electrocorticography (ECoG) monitoring significantly improved postoperative seizure control in patients with low-grade gliomas (LGGs), with 74.07% of patients achieving complete seizure freedom compared to 38.89% in those without ECoG guidance.

For patients with temporal lobe tumors, resection of the anterior part of the temporal lobe, where most epileptic discharges were detected, led to a 93.3% rate of satisfactory seizure control, highlighting the effectiveness of ECoG in identifying critical areas for resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgery guided with intraoperative electrocorticography in patients with low-grade glioma and refractory seizures. Yao, PS., Zheng, SF., Wang, F., et al.[2019]

Continuous electrocorticography (ECoG) monitoring during awake craniotomy for glioblastoma resection can detect electrographic seizures in real-time, which may help optimize surgical outcomes.

In a case study of a 68-year-old woman, the use of a novel 22-channel high-density hollow circular array allowed for effective monitoring during surgery, and she remained seizure-free three months post-operation, suggesting the potential safety and efficacy of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Seizure Detection During Active Resection of Glioblastoma Through a Novel Hollow Circular Electrocorticography Array. Domingo, RA., Vivas-Buitrago, T., De Biase, G., et al.[2022]

In a study of 586 patients undergoing glioma resection, stimulation-induced seizures (SIS) occurred in only 3.92% of cases, with the highest rates observed in the frontal lobe (8.5%).

The study found that higher stimulation currents did not correlate with identifying more functional cortical sites, suggesting that increasing stimulation may not enhance mapping effectiveness during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship Between Stimulation Current and Functional Site Localization During Brain Mapping. Muster, RH., Young, JS., Woo, PYM., et al.[2021]

High gamma electrocorticography (hgECOG) mapping identified functional motor areas in 85.7% of patients, outperforming electrical cortical stimulation (ECS), which identified them in 71.4% of patients, suggesting hgECOG may be more effective for motor mapping.

HgECOG mapping for language functions showed mixed results compared to ECS, with 40% of tasks aligning with ECS findings, but also revealing additional areas not identified by ECS, indicating hgECOG's potential to enhance language mapping without the risk of stimulation-induced seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[COMPARISON OF HIGH GAMMA ELECTROCORTICOGRAPHY AND DIRECT CORTICAL STIMULATION MAPPING OF CORTICAL FUNCTION IN AWAKE CRANIOTOMY: INITIAL EXPERIENCE]. Shahar, T., Gonen, L., Michaeli, A., et al.[2023]

Intraoperative electrocorticography was successfully used to record neural activity related to executive functions in three patients with diffuse low-grade glioma during awake surgery, showing significant increases in high-gamma power with increased task difficulty.

This study suggests that electrocorticography can complement traditional direct electrical stimulation methods for mapping executive functions, potentially improving surgical outcomes while preserving quality of life, although further research is needed to validate its clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative mapping of executive function using electrocorticography for patients with low-grade gliomas. Erez, Y., Assem, M., Coelho, P., et al.[2021]

Using direct electrical stimulation (DES) at a lower frequency of 10 Hz during awake neurosurgery allows for improved mapping of brain connectivity with higher spatial accuracy compared to the standard 60 Hz frequency.

The method involves differential recording of electro-corticographic (ECoG) signals, enabling the easy recording of cortico-cortical evoked potentials at a standard stimulation amplitude of 2 mA, enhancing the precision of functional brain mapping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A measure of cortico-cortical potentials evoked by 10 Hz direct electrical stimulation of the brain and by means of a differential recording mode of electrocorticographic signals. Vincent, M., Rossel, O., Duffau, H., et al.[2020]

Combining direct cortical stimulation with electrocorticographic recording enhances the accuracy of brain mapping during surgery, helping to identify essential brain areas more effectively.

This improved technique allows for real-time visualization of brain activity, which can help adjust stimulation parameters and better assess the connectivity of cerebral networks, potentially reducing the risk of neurological complications during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Interest of EEG recording during direct electrical stimulation for brain mapping function in surgery]. Trebuchon, A., Guye, M., Tcherniack, V., et al.[2012]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10393852/

Comparison of direct cortical stimulation and transcranial ... TMS is a noninvasive imaging method for the evaluation of eloquent brain areas that is not inferior compared to the invasive gold-standard imaging method (DCS).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6692891/

Direct Electrical Stimulation in Electrocorticographic Brain ... This greatly blunts the efficacy of cortical stimulation, and suggests that some of the published results using TES are due to mechanisms other than direct ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02754544

Electrocorticography in Mapping Functional Brain Areas ... ... Outcomes in Patients With Brain Tumors. Conditions. Brain Neoplasm ... Direct Cortical Electrical Stimulation; Electrocortical Stimulation Mapping ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S187887502301433X

Corticocortical Evoked Potentials in Eloquent Brain Tumor ... In this context, CCEP mapping represents a form of evoked effective connectivity, helping neurosurgeons in the safe removal of brain tumors in an eloquent area.

5. mdpi.com mdpi.com/2076-3425/14/9/867

Preoperative Cortical Mapping for Brain Tumor Surgery ... The aim of this study is to assess the efficacy of navigated TMS for cortical mapping in comparison to surgical mapping using direct electrical stimulation (DES) ...

6. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2019.00804/full

Direct Electrical Stimulation in Electrocorticographic Brain– ... In this article, we review ECoG electrodes, the physics and physiology of DES, and the use of electrical stimulation of the brain for the clinical treatment of ...

7. springermedicine.com springermedicine.com/brain-tumor/transcranial-magnetic-stimulation/comparison-of-direct-cortical-stimulation-and-transcranial-magne/25702966

Brain Tumor | Comparison of direct cortical stimulation and ... Comparison of direct cortical stimulation and transcranial magnetic stimulation in brain tumor surgery: systematic review and meta analyses.