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

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