Neuronal and Network Mechanisms of Electrocortical Stimulation

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06391294
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Focal cortical cooling — PROCEDURE
    Focal cortical cooling will be applied

Study Details

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.

Key Dates

Start date
May 17, 2024
Status verified
Sep 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Experimental group
    Single arm of the study

Primary Outcome Measure

Critical node decoding performance [ Time Frame: Up to 1 week during ECoG recording ]

Locations (3)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-
University of IowaIowa CityIowa52242-
Johns Hopkins UniversityBaltimoreMaryland21218-

Find similar trials in Chicago, IL

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
Northwestern University· Chicago, ILUniversity of Iowa· Iowa City, IAJohns Hopkins University· Baltimore, MD

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