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

NCT04531722 | Enrolling By Invitation

• 1 other identifier: 19-000398
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Detection of analytes/protein

  Presence of protein in the microdialysate

  Through study completion, up to 5 years

Study Arms (1)

drug-resistant temporal lobe epilepsy

EXPERIMENTAL

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.

Procedure: Intraoperative brain microdialysis

Interventions

Intraoperative brain microdialysis 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.

drug-resistant temporal lobe epilepsy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Charles Howe, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Model Details: We will establish intraoperative microdialysis in patients undergoing anterior temporal lobectomy for drug-resistant temporal lobe epilepsy. The human measurements will yield hypothesis-generating data and establish a methodological/logistical paradigm for future large-scale application of microdialysis in patients with drug refractory epilepsy.

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 28, 2020
• Study Start: March 27, 2019
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)