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

Mayo Clinic

Status and phase

Completed

Phase 1

Conditions

Epilepsy

Treatments

Procedure: Laser ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT01703143

10-007909

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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