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

Not Applicable

• Conditions: Epilepsy
• Interventions: Procedure: Intraoperative brain microdialysis

• Registration Number: NCT04531722
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-27
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-03
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
drug-resistant temporal lobe epilepsy	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. 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.

Primary Outcome Measures

Name	Time	Method
Detection of analytes/protein	Through study completion, up to 5 years	Presence of protein in the microdialysate

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States