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

Location:

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?

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 AEDs 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

Last updated:
12/2/2013
NCT ID:
NCT01703143
IRB Number:
10-007909