Electrocorticography for Brain Tumor
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Neurological motor deficits, Speech deficits, Impaired vision, others
No Placebo Group
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.
12345Is 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.
35678How 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.
12349Eligibility 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 18 years old or older.
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
Trial 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)
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Diagnostic (electrocorticography)Experimental Treatment2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
University of HoustonCollaborator
References
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]Direct electrical stimulation (DES) at 60 Hz is used to perform real-time functional mapping of the brain during wide-awake neurosurgery. The electrophysiological effects of DES are largely unknown, locally and at a more remote distance. Here, by lowering the DES frequency to 10 Hz and by using a differential recording mode of electro-corticographic (ECoG) signals to improve the focality, we were able to record cortico-cortical evoked potentials easily with standard current amplitude of stimulation (2 mA). DES applied at 10 Hz and differential recording of ECoG could be used to map on-line the connectivity between different sub-cortical and cortical areas with a higher spatial accuracy.
The utility of intraoperative ECoG in tumor-related epilepsy: Systematic review. [2022]Epilepsy is one of the most common clinical manifestations of primary brain tumors. Intraoperative electrocorticography (ECoG) has been widely used in tumor resection. We aim to describe the indication and utility of ECoG during brain tumor surgery.
Intraoperative Seizure Detection During Active Resection of Glioblastoma Through a Novel Hollow Circular Electrocorticography Array. [2022]Data supporting the use of electrocorticography (ECoG) monitoring during electrical stimulation in awake craniotomies for resection of supratentorial neoplasms is robust, but its applicability during active resection is often limited by the inability to keep the array in place. Given the known survival benefit of gross total resection in glioma surgery, novel approaches to surgical monitoring are warranted to maximize safe resection and optimize surgical outcomes in patients with glioblastoma.
Surgery guided with intraoperative electrocorticography in patients with low-grade glioma and refractory seizures. [2019]OBJECTIVE Using intraoperative electrocorticography (ECoG) to identify epileptogenic areas and improve postoperative seizure control in patients with low-grade gliomas (LGGs) remains inconclusive. In this study the authors retrospectively report on a surgery strategy that is based on intraoperative ECoG monitoring. METHODS A total of 108 patients with LGGs presenting at the onset of refractory seizures were included. Patients were divided into 2 groups. In Group I, all patients underwent gross-total resection (GTR) combined with resection of epilepsy areas guided by intraoperative ECoG, while patients in Group II underwent only GTR. Tumor location, tumor side, tumor size, seizure-onset features, seizure frequency, seizure duration, preoperative antiepileptic drug therapy, intraoperative electrophysiological monitoring, postoperative Engel class, and histological tumor type were compared between the 2 groups. RESULTS Univariate analysis demonstrated that tumor location and intraoperative ECoG monitoring correlated with seizure control. There were 30 temporal lobe tumors, 22 frontal lobe tumors, and 2 parietal lobe tumors in Group I, with 18, 24, and 12 tumors in those same lobes, respectively, in Group II (p
[Interest of EEG recording during direct electrical stimulation for brain mapping function in surgery]. [2012]Brain tumor surgery is at risk when lesions are located in eloquent areas. The interindividual anatomo-functional variability of the central nervous system implies that brain surgery within eloquent regions may induce neurological sequelae. Brain mapping using intraoperative direct electrical stimulation in awake patients has been for long validated as the standard for functional brain mapping. Direct electrical stimulation inducing a local transient electrical and functional disorganization is considered positive if the task performed by the patient is disturbed. The brain area stimulated is then considered as essential for the function tested. However, the exactitude of the information provided by this technique is cautious because the actual impact of cortical direct electrical stimulation is not known. Indeed, the possibility of false negative (insufficient intensity of the stimulation due to the heterogeneity of excitability threshold of different cortical areas) or false positive (current spread, interregional signal propagation responsible for remote effects, which make difficult the interpretation of positive or negative behavioural effects) constitute a limitation of this technique. To improve the sensitivity and specificity of this technique, we used an electrocorticographic recording system allowing a real time visualization of the local. We provide here evidence that direct cortical stimulation combined with electrocorticographic recording could be useful to detect remote after discharge and to adjust stimulation parameters. In addition this technique offers new perspective to better assess connectivity of cerebral networks.
Early Postoperative Seizures Following Awake Craniotomy and Functional Brain Mapping for Lesionectomy. [2023]Awake craniotomy with electrocorticography (ECoG) and direct electrical stimulation (DES) facilitates lesionectomy while avoiding adverse effects. Early postoperative seizures (EPS), occurring within 7 days following surgery, can lead to morbidity. However, risk factors for EPS after awake craniotomy including clinical and ECoG data are not well defined.
[COMPARISON OF HIGH GAMMA ELECTROCORTICOGRAPHY AND DIRECT CORTICAL STIMULATION MAPPING OF CORTICAL FUNCTION IN AWAKE CRANIOTOMY: INITIAL EXPERIENCE]. [2023]The use of intraoperative electrical cortical stimulation (ECS) to map function is the standard of care in modern neurosurgery. Recently, high gamma electrocorticography (hgECOG) mapping has had encouraging results. In this study we aim to compare hgECOG and fMRI with ECS for motor and language mapping.
The Relationship Between Stimulation Current and Functional Site Localization During Brain Mapping. [2021]Gliomas are often in close proximity to functional regions of the brain; therefore, electrocortical stimulation (ECS) mapping is a common technique utilized during glioma resection to identify functional areas. Stimulation-induced seizure (SIS) remains the most common reason for aborted procedures. Few studies have focused on oncological factors impacting cortical stimulation thresholds.
Intraoperative mapping of executive function using electrocorticography for patients with low-grade gliomas. [2021]Intraoperative functional mapping with direct electrical stimulation during awake surgery for patients with diffuse low-grade glioma has been used in recent years to optimize the balance between surgical resection and quality of life following surgery. Mapping of executive functions is particularly challenging because of their complex nature, with only a handful of reports published so far. Here, we propose the recording of neural activity directly from the surface of the brain using electrocorticography to map executive functions and demonstrate its feasibility and potential utility.