Stereotactic Laser Ablation for Temporal Lobe Epilepsy
(SLATE Trial)

Recruiting in Palo Alto (17 mi)

+22 other locations

Overseen byMichael Sperling, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: MedtronicNeuro

No Placebo Group

Trial Summary

What is the purpose of this trial?

The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE).

Research Team

Robert Gross, MD, PhD

Principal Investigator

Emory University

Michael Sperling, MD

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

This trial is for people with drug-resistant mesial temporal lobe epilepsy who haven't had success with a vagus nerve stimulator or have at least one seizure per month. Participants must be on stable epilepsy medications, able to follow the study plan, and have MRI and EEG results supporting MTLE diagnosis. It's not for pregnant women, those with MRI-incompatible implants, prior brain surgery for seizures, certain EEG patterns suggesting non-MTLE seizures, dementia, severe psychiatric issues, or allergies to gadolinium.

Inclusion Criteria

Willing and able to comply with protocol requirements

Able to complete study assessments in English or Spanish language

You have a history of epilepsy that does not respond to medication in the part of the brain called the mesial temporal lobe.

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Exclusion Criteria

You have ongoing abnormal brain activity on an EEG test, which shows spikes or slowing in certain areas of the brain.

You are allergic to gadolinium.

You have a serious mental illness or medical condition that could make the Visualase procedure unsafe or affect the tests of thinking and emotions.

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Treatment Details

Interventions

Visualase MRI-Guided Laser Ablation (Device)

Trial OverviewThe trial tests the Visualase MRI-guided laser ablation system's safety and effectiveness in treating mesial temporal epilepsy. Patients will undergo this minimally invasive procedure where laser energy is used to remove brain tissue causing seizures while being monitored by an MRI.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Visualase MRI-guided laser ablation procedure