A Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy
Rochester, Minn., Jacksonville, Fla.
Trial status: Open for Enrollment
Why is this study being done?
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.
Who is eligible to participate?
- 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.
- 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