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

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

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.

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.

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