Intraoperative Brain Microdialysis to Assess Neuroinflammation in Epileptic Tissue Immediately Prior to Surgical Resection.

NCT ID: NCT04531722

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-27
• Study Completion Date: 2026-12-31

Brief Summary

This research study will investigate the fluid from the area of the brain that is being removed during clinical epilepsy surgery. The goal is to analyze this fluid for inflammatory markers that can potentially help identify new strategies in the future to control seizures in individuals with epilepsy who fail to respond to currently available drugs.

Conditions

Epilepsy

Study Design

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

Study Groups

drug-resistant temporal lobe epilepsy

Our current standard practice is to use a lateral approach through the middle temporal gyrus to place 3 depth electrodes targeting the hippocampus for intraoperative verification of pathological epileptiform activity prior to resection. Our research protocol will add one FDA approved electrode that has a central cannula for insertion of a microdialysis probe. The electro-physiological data that will be gathered is not altered and this methodology will not impact standard clinical care, except and will not to extend the duration in the OR - the measurements will occur during the clinical electrocorticography (ECoG; intracranial electroencephalography (iEEG)) procedure by 15 min.

Group Type: EXPERIMENTAL

Intraoperative brain microdialysis

Intervention Type: PROCEDURE

Our current standard practice is to use a lateral approach through the middle temporal gyrus to place 3 depth electrodes targeting the hippocampus for intraoperative verification of pathological epileptiform activity prior to resection. Our research protocol will add one FDA approved electrode that has a central cannula for insertion of a microdialysis probe.

Interventions

Intraoperative brain microdialysis

Our current standard practice is to use a lateral approach through the middle temporal gyrus to place 3 depth electrodes targeting the hippocampus for intraoperative verification of pathological epileptiform activity prior to resection. Our research protocol will add one FDA approved electrode that has a central cannula for insertion of a microdialysis probe.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Failure to respond to at least two trials of anti-seizure drugs with different mechanisms of action
• Normal MRI

Exclusion Criteria

• Active immunomodulatory therapy
• Autoimmune disorder
• Signs or symptoms consistent with comorbid infection
• Oncological comorbidity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Charles L. Howe

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles Howe, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

19-000398

Identifier Type: -

Identifier Source: org_study_id