Neuronal and Network Mechanisms of Electrocortical Stimulation

NCT06391294 | Enrolling By Invitation DMC

• 1 other identifier: STU00219749
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Epilepsy; Brain Tumor Adult

Keywords

Electrocortical Stimulation; Electrocorticography

Outcome Measures

Primary Outcomes (1)

• Critical node decoding performance

  Accuracy at decoding critical nodes from network connectivity metrics using machine learning algorithms.

  Up to 1 week during ECoG recording

Secondary Outcomes (1)

• Language function

  Up to 4 hours during ECoG recording

Study Arms (1)

Experimental group

EXPERIMENTAL

Single arm of the study

Procedure: Focal cortical cooling

Interventions

Focal cortical cooling PROCEDURE

Focal cortical cooling will be applied

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Johns Hopkins University: collaborator
• University of Iowa: collaborator
• Indiana University: collaborator

Study Sites (3)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Marc Slutzky

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 30, 2024
• Study Start: May 17, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

US (3)