What side effects are associated with this type of intervention?

Common treatments for epilepsy include lamotrigine, carbamazepine, valproate, levetiracetam, and zonisamide. Lamotrigine can cause side effects such as rash, dizziness, and headache. Carbamazepine is associated with dizziness, drowsiness, and potential blood disorders. Valproate may lead to weight gain, hair loss, and liver toxicity. Levetiracetam's side effects include fatigue, irritability, and dizziness. Zonisamide can cause drowsiness, loss of appetite, and kidney stones. These treatments are generally effective but require monitoring for these potential adverse effects.

What prior FDA approvals exist?

Several antiseizure medications have received FDA approval for the treatment of epilepsy, focusing on their efficacy and safety in controlling seizures. Notable drugs include valproate, levetiracetam, carbamazepine, and lamotrigine, which have been widely used in clinical practice. Additionally, newer treatments like lacosamide and zonisamide have also been approved. These medications are often evaluated for their potential to reduce neuroinflammation, which is a key area of interest in developing new seizure control strategies. The study of inflammatory markers in epileptic tissue aims to identify novel targets for these and future antiepileptogenic treatments.

What other types of research exist?

Promising novel alternatives for epilepsy treatment in 2024 include: 1) Gene therapy, which targets specific genetic mutations associated with epilepsy. 2) Neurostimulation techniques such as responsive neurostimulation (RNS) and transcranial magnetic stimulation (TMS) that modulate brain activity to prevent seizures. 3) Advanced neuroimaging techniques for precise localization of epileptic foci, aiding in targeted surgical interventions. 4) Personalized medicine approaches using pharmacogenomics to tailor anti-epileptic drug therapy based on individual genetic profiles. 5) Development of new anti-epileptic drugs targeting novel pathways involved in seizure generation and propagation.

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Intraoperative Brain Microdialysis for Epilepsy

N/A

Waitlist Available

Led By Charles Howe, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be between 18 and 65 years old

Must not have

Active immunomodulatory therapy

Signs or symptoms consistent with comorbid infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at brain fluid from people with epilepsy who are having surgery. They hope to find new ways to control seizures for people who don't respond to drugs.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves standard surgical procedures without additional drugs being tested, side effects are primarily those associated with typical risks of brain surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on a treatment that boosts my immune system.

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I am showing signs of having another infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Detection of analytes/protein

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: drug-resistant temporal lobe epilepsyExperimental Treatment1 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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for epilepsy primarily include antiepileptic drugs (AEDs) such as lamotrigine, valproate, and carbamazepine. These medications work by stabilizing neuronal membranes and reducing excitability through various mechanisms. Lamotrigine inhibits voltage-sensitive sodium channels, valproate increases gamma-aminobutyric acid (GABA) levels, and carbamazepine also blocks sodium channels. These mechanisms are crucial for epilepsy patients as they help to prevent the abnormal electrical activity in the brain that leads to seizures. Understanding and targeting inflammatory markers, as explored in the trial, could provide new avenues for treatment, especially for patients who do not respond to current AEDs, by addressing underlying neuroinflammation that may contribute to seizure activity.

New Aspects of VEGF, GABA, and Glutamate Signaling in the Neocortex of Human Temporal Lobe Pharmacoresistant Epilepsy Revealed by RT-qPCR Arrays.The Effect of Statins in Epilepsy: A Systematic Review.