Functional Brain Mapping for Patients with Epilepsy

NCT ID: NCT05755919

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2027-03-31

Brief Summary

We aim to determine the clinical utility of 'dynamic tractography': a novel method for visualizing electrical neural transfers that incorporates the underlying white matter tracts and supporting linguistic processing. We will also determine how well objective electrophysiology biomarkers will improve the prediction of language outcomes following epilepsy surgery. This project will ultimately optimize understanding of how the human brain develops its language network dynamics.

Detailed Description

We will determine the utility of a novel brain mapping technique for epilepsy presurgical evaluation, referred to as 'six-dimensional (6D) dynamic tractography'. This innovative program animates the rapid neural propagations along MRI-defined, 3D white matter tracts that connect regions supporting cognitive functions. Specifically, it will use event-related high gamma activity to localize the regions supporting specific linguistic functions and compute the velocity and strength of neural propagations based on the latency and amplitude of early neural responses to single-pulse electrical stimulation. We expect that considering both the negative effect of damaged white matter tracts and the positive effect of seizure control will help optimize the model's performance in predicting postoperative language outcomes; this will be accomplished by incorporating the 6D dynamic tractography and objective epilepsy biomarkers, including spontaneous high-frequency oscillations (HFOs) coupled to slow-waves, into our predictive model. By also identifying and considering the physiological high gamma augmentation strictly time-locked to stimuli and behaviors, our innovative intracranial EEG analysis will better distinguish the randomly-occurring pathologic HFOs. Another significant advancement provided by our model is its independence of conventional electrical stimulation mapping, which can acutely elicit seizures and fail to satisfactorily localize language areas in certain patient subsets. Additionally, this project will use 6D dynamic tractography to provide an explicit neurobiological model of language network dynamics, allowing us to tease apart the specific pathways originating from temporal lobe cortices that support the lexical retrieval of auditory or visual domains. Our prior project indicated that the arcuate fasciculus fibers support the direct transfer of lexical representations of auditory sentences. We will now determine whether the lexical representations of visual objects are likewise transferred via the arcuate fasciculus or others, including the fusiform-parietal fasciculus. To accomplish these goals, this project will prospectively recruit a new cohort of 80 epilepsy patients - age range: 0.5 to 21 years - undergoing extraoperative intracranial EEG recording and subsequent resective surgery. Finally, we will determine if the human brain creates and strengthens language-related functional parcellations throughout development. It has been suggested that the adult brain efficiently activates the posterior superior-temporal gyrus (STG) only during sound onset to decode the boundary between sounds. In contrast, the anterior STG shows sustained activation during an auditory stimulus to encode the phonetic features. We will determine if such a functional parcellation is more evident in older individuals, whose brains are more developed. While providing hypotheses focusing on specific brain regions, we will perform all of the proposed analyses at the whole-brain level. We will make all data and codes publicly available to facilitate external validation and implementation.

Conditions

Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with epilepsy

Epilepsy surgery will be performed as a part of the clinical management of patients with drug-resistant epilepsy.

Group Type: OTHER

Epilepsy surgery

Intervention Type: PROCEDURE

Epilepsy surgery will be performed as a part of the clinical management of patients with drug-resistant epilepsy.

Interventions

Epilepsy surgery

Epilepsy surgery will be performed as a part of the clinical management of patients with drug-resistant epilepsy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Epilepsy surgery with extraoperative intracranial EEG recording with subdural or depth electrodes.

Exclusion Criteria

• Patients with a malignant brain tumor, or progressive neurodegenerative or metabolic disorders who are not considered candidates for intracranial EEG recording.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Eishi Asano

Professor of Pediatrics and Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eishi Asano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Children's Hospital of Michigan

Detroit, Michigan, United States

Site Status: RECRUITING

Wayne State University

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Eishi Asano, MD, PhD

Role: CONTACT

easano@med.wayne.edu

313-745-5563

Facility Contacts

Eishi Asano, MD, PhD

Role: primary

easano@med.wayne.edu

313-745-5563

Eishi Asano, MD, PhD

Role: primary

easano@med.wayne.edu

313-745-5563

Other Identifiers

048404MP2E

Identifier Type: -

Identifier Source: org_study_id