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NCT06391294Enrolling by invitation

Neuronal and Network Mechanisms of Electrocortical Stimulation

Source: ClinicalTrials.gov · Last updated 7 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
65 (estimated)
First submitted
5 Apr 2024
Start date
17 May 2024
Primary completion date
30 Jun 2029
Lead sponsor
Northwestern University
Diseases
Epilepsy
NCT number
NCT06391294

What you commit to

  • Study type: Interventional
  • Planned participants: 65
  • From 17 May 2024 to the primary completion date, 30 Jun 2029
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Ferromagnetic implants that are MRI incompatible or other contraindications to MRI

Other illness

  • Significant language or speech impairment, including but not limited to aphasia, dysarthria, and apraxia of speech, consistently preventing patient from speaking words

Other

  • 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)
  • Pregnancy

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Johns Hopkins University
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
University of Iowa
Coordinator of this site? Confirm its status
Iowa CityUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.