Intraoperative Brain Microdialysis for Epilepsy

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Anti-seizure drugs

Must not be taking: Immunomodulatory therapy

Disqualifiers: Autoimmune disorder, Infection, Oncological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

3 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves epilepsy surgery, it's best to discuss your current medications with the study team.

What data supports the effectiveness of the treatment Intraoperative Brain Microdialysis for epilepsy?

Research shows that intraoperative brain microdialysis can monitor changes in brain chemistry during surgery, which may help in understanding and managing epilepsy. It has been used to detect changes in neurochemicals during seizures, providing insights that could lead to better treatment strategies. ^{1 2 3 4 5}

Is intraoperative brain microdialysis safe for humans?

Intraoperative brain microdialysis has been used in patients with epilepsy to monitor brain chemicals during surgery, and while it involves placing electrodes in the brain, there is no specific mention of safety issues directly related to the microdialysis itself in the provided studies. ^{1 4 5 6 7}

How does the treatment Intraoperative Brain Microdialysis for Epilepsy differ from other treatments for this condition?

Intraoperative Brain Microdialysis is unique because it involves directly measuring neurochemicals in the brain during surgery, allowing for real-time monitoring of brain activity and chemical changes associated with epilepsy. This approach provides detailed insights into the brain's environment, which is not possible with standard epilepsy treatments that typically focus on controlling seizures with medication. ^{1 2 4 8 9}

Research Team

Charles Howe, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals with epilepsy who haven't improved after trying at least two different anti-seizure medications. They should have a normal MRI scan and not be on immune-modifying treatments, have autoimmune disorders, infections, or cancer-related health issues.

Inclusion Criteria

I have tried at least two different seizure medications without success.

Your MRI scan shows no abnormalities.

Exclusion Criteria

You have another cancer-related health condition.

You have an autoimmune disorder.

I am showing signs of having another infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intraoperative Procedure

Intraoperative brain microdialysis to assess neuroinflammation in epileptic tissue immediately prior to surgical resection

15 minutes

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

• Intraoperative Brain Microdialysis

Trial Overview The study involves collecting and analyzing fluid from the brain during epilepsy surgery to look for inflammation markers. This could lead to new seizure control methods for drug-resistant epilepsy in the future.

Participant Groups

Group I: drug-resistant temporal lobe epilepsy Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Cerebral microdialysis combined with single-neuron and electroencephalographic recording in neurosurgical patients. Technical note. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Microdialysis: intraoperative and posttraumatic applications in neurosurgery. [2005]

3. Austria pubmed.ncbi.nlm.nih.gov

The diagnostic accuracy of brain microdialysis during surgery: a qualitative systematic review. [2018]

4. Austria pubmed.ncbi.nlm.nih.gov

Hippocampal microdialysis during spontaneous intraoperative epileptiform activity. [2013]

5. Ireland pubmed.ncbi.nlm.nih.gov

Seizure related elevations of extracellular amino acids in human focal epilepsy. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

A steroid derivative (RU 5135) exhibits epileptogenicity in the presence of deficient blood-brain barrier. [2019]

7. India pubmed.ncbi.nlm.nih.gov

Iatrogenic Seizures during Intraoperative Transcranial Motor-Evoked Potential Monitoring. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Epilepsy surgery: perioperative investigations of intractable epilepsy. [2005]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Elevated extracellular levels of glutamate, aspartate and gamma-aminobutyric acid within the intraoperative, spontaneously epileptiform human hippocampus. [2019]