Recruiting

Observational Study

Sponsor:

Wayne State University

Code:

NCT05755919

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Epilepsy surgery

Study Details

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.

Conditions

Epilepsy

Study ID

NCT05755919

Start date

May 16, 2022

Status verified date

Feb, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Patients with epilepsy

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.

Primary outcome measure

  • Language outcome [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Eishi Asano, MD, PhD

313-745-5563easano@med.wayne.edu

Locations

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Eishi Asano, MD, PhD

313-745-5563easano@med.wayne.edu

Wayne State University

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Eishi Asano, MD, PhD

313-745-5563easano@med.wayne.edu

More Information

Sponsor

Wayne State University

Last update posted

Feb 26, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2025-02-26.