Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy

Study Overview
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Brief Summary
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To investigate whether MR-guided laser induced thermal therapy in patients diagnosed with focal lesional epilepsy using the Visualase Thermal Therapy System is both a feasible and safe minimally invasive technique for control of seizures in such patients.

Detailed Description
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In this study, we propose to evaluate a novel, thermal therapy and feedback system (Visualase® Thermal Therapy System) as an alternative to surgical resection for the treatment of focal lesional epilepsy in patients that are considered high risk surgical candidates. This system includes the FDA-cleared Visualase Cooled Laser Applicator System (VCLAS), which allows delivery of laser energy while the patient is being imaged by an MRI unit. The Visualase® System works via real-time MR thermal imaging (MRTI) to provide information on the thermal dose delivered to the target, resulting in a more precise and controlled delivery which has heretofore not been possible with previous non-image guided laser technology. We hypothesize that the Visualase system can be used in patients refractory to medication therapy in a minimally invasive procedure to destroy epileptogenic focal lesions in the brain.

Official Title
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A Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy

Conditions
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Epilepsy

Intervention / Treatment
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* Procedure: Laser ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older at entry to protocol. History of MRI lesional-related epilepsy for at least one year. Failure to respond to more than 2 anti-epileptic drugs at adequate dose and duration. Candidate for resective epilepsy surgery. Considered healthy enough to undergo surgery with general anesthesia. The patient has given written informed consent after the nature of the study and alternative treatment options have been explained. Must have 3 months of seizure frequency recorded prior to procedure. Exclusion Criteria: Presence of any non-MRI compatible implanted electronic device. Presence of a metallic prosthetic or implant including artificial hips, knees, joints, or rods and screws. Active Major depression History of Suicide attempts History of Non-Epileptic Behavioral Spells

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Ablation<br>Laser ablation of focal lesions in patients with medically refractory partial epilepsy. | Procedure: Laser ablation<br>* Laser ablation of focal lesions in patients with medically refractory partial epilepsy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of seizures recorded in seizure diary |  | Baseline to 1 year |