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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to control seizures in people with epilepsy who don't respond to current medications. Researchers will examine brain fluid during epilepsy surgery to identify inflammatory markers that might aid in developing future treatments. It targets individuals who have tried at least two different anti-seizure drugs without success and have a normal MRI scan. The research uses a special probe (intraoperative brain microdialysis) during brain surgery to gather data, without altering standard care or extending the surgery. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for epilepsy.

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 prior data suggests that intraoperative brain microdialysis is safe for epilepsy surgery?

Research has shown that using a small probe during brain surgery for epilepsy, known as intraoperative brain microdialysis, is generally safe. This technique analyzes fluid from the brain tissue being removed without disrupting the usual surgical process or extending operating time.

In past studies on epilepsy surgery, patients have tolerated similar techniques well, with no major side effects reported, indicating the procedure's general safety. The use of an FDA-approved electrode further enhances its safety.

Although direct data on this specific method is limited, existing information and its regular use in surgeries suggest it is safe for patients. Prospective participants should discuss any concerns with the medical team conducting the trial to understand its relevance to their situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intraoperative brain microdialysis for drug-resistant temporal lobe epilepsy because it offers a new way to gather real-time biochemical data from the brain. Unlike standard treatments like medication or surgical resection, this technique uses a specialized electrode with a microdialysis probe to measure chemical changes directly in the brain during surgery. This could provide deeper insights into epileptic activity without altering the standard surgical procedure, potentially leading to more effective and personalized treatment strategies in the future.

What evidence suggests that intraoperative brain microdialysis is effective for epilepsy?

Research has shown that surgery can be highly effective for individuals with drug-resistant temporal lobe epilepsy. Studies indicate that about 58-70% of patients become seizure-free after surgery. This includes procedures like medial temporal lobectomy, which targets the brain area often associated with these seizures. In this trial, researchers use a technique called intraoperative brain microdialysis to study brain fluid during surgery. This method helps identify markers that might improve future epilepsy management. Overall, evidence strongly supports surgery as a means to reduce seizures and enhance quality of life for these patients. ^{1 3 4 6 7}

Who Is on the Research Team?

Charles Howe, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-epilepsy-2-2019-e8512

Intraoperative Brain Microdialysis for Epilepsy This research study will investigate the fluid from the area of the brain that is being removed during clinical epilepsy surgery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11971703/

Surgical Outcomes of Medial Temporal Lobectomy in Drug ... A medial temporal lobectomy, alone or in combination with amygdalohippocampectomy, serves as an effective surgical treatment for drug-resistant TLE.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1878875025000853

Comparative Efficacy of Surgical Strategies for Drug ... Surgical treatment for drug-resistant temporal lobe epilepsy can reduce seizure recurrence (58% of patients achieving seizure-free status) and improve quality ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.777845/full

A Systematic Review and Meta-Analysis of Outcomes Mesial temporal lobe epilepsy (MTLE) is the most common form of drug resistant focal epilepsy. Surgery may lead to long-term seizure remission if the ...

5. aepi.biomedcentral.com aepi.biomedcentral.com/articles/10.1186/s42494-024-00190-3

Outcome predictors in patients with temporal lobe epilepsy ... Anterior temporal lobectomy can effectively reduce the seizure recurrence rate in epilepsy patients, with 60–70% of drug-refractory TLE patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11472416/

Optimizing outcomes in drug-resistant mesial temporal ... This study provides valuable insights into the significance of the amygdala and rhinal cortex as ROIs in the preoperative evaluation of patients with MTLE.

7. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/epilepsy

Epilepsy Clinical Trials The purpose of this study is to investigate the feasibility and safety of thalamic CL stimulation in restoring consciousness in epilepsy patients.