Neuronal and Network Mechanisms of Electrocortical Stimulation

Study Purpose

Electrocortical stimulation (ECS) mapping is a procedure used during brain surgeries, for example when treating diseases like epilepsy or when removing brain tumors. ECS mapping helps surgeons locate areas of the cerebral cortex (the outer part of the brain) that are important for everyday tasks like movement and speech. ECS mapping has been used for decades, and is considered the "gold-standard" tool for locating important areas of cortex. Despite this long history, there is still no clear understanding of exactly how ECS works. The goal of this study is to learn details about the effects ECS has on the brain. The main questions the study aims to answer are: 1) how ECS affects the neurons of the cortex at the stimulation site; and 2) how ECS impacts brain regions that are critically important for human speech and language. These so-called "critical sites" can be physically distant from one another on the brain's surface, requiring extensive ECS mapping and long surgeries. Critical sites are thought to be part of a speech/language network of brain areas, and so the study's goal is to learn about how they are connected. In some participants, the brain's surface will also be slightly cooled. This is a painless procedure that does not harm the brain's function, but could provide insight as to which parts of the brain (the surface, or deeper parts) are responsible for the effects of ECS. By improving the understanding of how ECS affects the brain and improving the ability to identify critical sites, this study could potentially lead to shorter surgeries and better outcomes for future individuals who need this care. Participants will be recruited from among individuals who are undergoing brain surgery for epilepsy treatment or tumor removal. Participants will complete simple tasks like reading words or naming pictures, similar to standard testing that is already performed during their hospital stay.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Requiring awake, cortical mapping for brain tumor resection or implantation of intracranial electrodes for extraoperative monitoring for epilepsy.
  • - For extraoperative patients: Planned electrode coverage including at least parts of frontal and temporal or parietal lobes, preferably both anterior (inferior frontal gyrus) and posterior language areas (superior temporal gyrus) in the language dominant hemisphere.
  • - For intraoperative patients: Planned craniotomy including parts of both frontal and temporal anterior and posterior language areas in the language dominant hemisphere.

Exclusion Criteria:

  • - Significant language or speech impairment, including but not limited to aphasia, dysarthria, and apraxia of speech, consistently preventing patient from speaking words.
  • - Non English-speaking (because this is a study of language networks, and second language could be encoded differently) - Impaired cognitive function, as determined by neurological testing, such that the patient cannot follow test instructions or provide written informed consent.
  • - Tumor infiltrating, or within 1 cm of, multiple of the cortical or subcortical areas studied in this proposal (inferior frontal gyrus, precentral gyrus, superior temporal gyrus) - Ferromagnetic implants that are MRI incompatible or other contraindications to MRI.
- Pregnancy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06391294
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Northwestern University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Marc Slutzky
Principal Investigator Affiliation Northwestern University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Epilepsy, Brain Tumor Adult
Additional Details

Electrocortical stimulation (ECS) mapping has been used routinely for many decades to inform surgeons on brain areas to avoid when planning surgical resections for tumors or epilepsy. In particular, those areas that are "critical" for speech and language are important to identify. Yet, despite its long history of clinical use, the precise mechanisms of ECS are poorly understood. For example, it is not known how different cortical layers and cell types respond to ECS. Moreover, it is not even clear whether ECS' behavioral effects are due to affecting the underlying cortex alone, causing trans-synaptic activation of other cortices, or directly affecting both the cortex and underlying white matter. A primary objective of this project is to determine the effects of ECS on the cortical network and subcortical white matter. This objective will be tested in two ways. First, the study will determine the relationship between ECS' effects and cortical connectivity patterns. This will be accomplished using graph theory metrics to analyze electrocorticography (ECoG) and functional magnetic resonance imaging (fMRI) from people with epilepsy or brain tumors. This will allow the recording of intracranial EEG (ECoG or stereo EEG) without adding substantial extra risk from the planned clinical treatment for these conditions. The study will investigate both static and dynamic network connectivity patterns, defined using static and dynamic graph metrics that measure connectivity at different scales (local, inter-regional, global). The study hypothesizes that structural (a.k.a. anatomical) and functional connectivity patterns of a cortical site determine its significance to the language network. To test this hypothesis, the study will use measures of structural and functional connectivity to predict which nodes are labeled critical by ECS. Second, the study will test the hypothesis that ECS' behavioral effects also depend on directly perturbing cortico-cortical white matter. The study will use focal cortical cooling as a way to test the respective effects on language function of cooling (which inhibits only the cortex) compared to ECS (which may perturb cortex and underlying white matter), as well as combined ECS and cooling.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Northwestern University, Chicago, Illinois

Status

Address

Northwestern University

Chicago, Illinois, 60611

University of Iowa, Iowa City, Iowa

Status

Address

University of Iowa

Iowa City, Iowa, 52242

Johns Hopkins University, Baltimore, Maryland

Status

Address

Johns Hopkins University

Baltimore, Maryland, 21218

Stay Informed & Connected