Epilepsy
Conditions
Brief summary
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
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.
Interventions
PROCEDURELaser ablation
Laser ablation of focal lesions in patients with medically refractory partial epilepsy.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of seizures recorded in seizure diary | Baseline to 1 year |
Countries
United States
Outcome results
None listed