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

Trial Summary

What is the purpose of this trial?

This pilot clinical trial studies how well electrocorticography works in mapping functional brain areas during surgery in patients with brain tumors. Using a larger than the standard mapping grid currently used during brain tumor surgery or a high-definition grid for electrocorticogram brain mapping may help doctors to better identify which areas of the brain are active during specific limb movement and speech during surgery in patients with brain tumors.

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 data supports the effectiveness of the treatment Direct Electrocortical Stimulation and Electrocorticography (ECoG) for brain tumors?

Research shows that using ECoG during brain tumor surgery can help identify areas causing seizures, which may improve seizure control after surgery. Additionally, combining direct electrical stimulation with ECoG can enhance brain mapping accuracy, potentially leading to safer and more effective tumor removal. ^{1 2 3 4 5}

Is electrocorticography (ECoG) safe for use in brain tumor surgeries?

Electrocorticography (ECoG) and direct electrical stimulation are generally considered safe for brain mapping during surgery, but there is a risk of seizures shortly after the procedure. These techniques are used to avoid damaging important brain areas, but they can sometimes cause temporary disruptions in brain function. ^{3 5 6 7 8}

How is the treatment using electrocorticography for brain tumors different from other treatments?

This treatment is unique because it uses electrocorticography (ECoG) to monitor brain activity directly from the brain's surface during surgery, helping to map critical functions and improve the precision of tumor removal. It also involves direct electrical stimulation to identify and preserve important brain areas, which can enhance surgical outcomes and potentially improve seizure control in patients with brain tumors. ^{1 2 3 4 9}

Research Team

Sujit S. Prabhu

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The utility of intraoperative ECoG in tumor-related epilepsy: Systematic review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Intraoperative Seizure Detection During Active Resection of Glioblastoma Through a Novel Hollow Circular Electrocorticography Array. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Surgery guided with intraoperative electrocorticography in patients with low-grade glioma and refractory seizures. [2019]

5. France pubmed.ncbi.nlm.nih.gov

[Interest of EEG recording during direct electrical stimulation for brain mapping function in surgery]. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

Early Postoperative Seizures Following Awake Craniotomy and Functional Brain Mapping for Lesionectomy. [2023]

7. Israel pubmed.ncbi.nlm.nih.gov

[COMPARISON OF HIGH GAMMA ELECTROCORTICOGRAPHY AND DIRECT CORTICAL STIMULATION MAPPING OF CORTICAL FUNCTION IN AWAKE CRANIOTOMY: INITIAL EXPERIENCE]. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The Relationship Between Stimulation Current and Functional Site Localization During Brain Mapping. [2021]

9. Austria pubmed.ncbi.nlm.nih.gov

Intraoperative mapping of executive function using electrocorticography for patients with low-grade gliomas. [2021]