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NCT04531722 Clinical Trial

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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04531722
Other study ID # 19-000398
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 27, 2019
Est. completion date March 2024

Study information
Verified date October 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 3
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 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.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Detection of analytes/protein Presence of protein in the microdialysate Through study completion, up to 5 years
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