Characterization and Analysis of Evoked Cortical Responses in Participants With Medication-intractable Epilepsy

NCT07014592 | Recruiting FDA Device

• 1 other identifier: HUM00258281
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to study how the brain reacts to a small electrical signal. Researchers will be using a novel combination of recording electrodes. The researchers will measure the brain response from these electrodes.

Conditions

Intractable Epilepsy

Outcome Measures

Primary Outcomes (2)

• Characterization of time-frequency data

  From recording electrodes

  During a 20 minute research phase of a clinically indicated surgery

• Characterization of local field responses (LFPs)

  From recording electrodes

  During a 20 minute research phase of a clinically indicated surgery

Study Arms (1)

Medication-intractable epilepsy

EXPERIMENTAL

Device: stimulating probes and electrodes

Interventions

stimulating probes and electrodes DEVICE

Subdural electrodes and/or ball tip probes will be used intraoperatively to provide electrical stimulation to the brain.

Medication-intractable epilepsy

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with medication intractable epilepsy who are recommended to undergo brain surgery to remove a "seizure" focus
• Can provide informed consent for the study and willing to participate

You may not qualify if:

• Presence of a permanent electronic implant
• Any chronic medical conditions that prevent safe placement of electrodes

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Electrodes

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Matthew Willsey, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ron Ball

CONTACT

734 936-7010; rmball@umich.edu

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: Assistant Professor of Neurosurgery

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 11, 2025
• Study Start: May 5, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)