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

NCT ID: NCT01703143

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-01-31

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.

Conditions

Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser Ablation

Laser ablation of focal lesions in patients with medically refractory partial epilepsy.

Group Type: EXPERIMENTAL

Laser ablation

Intervention Type: PROCEDURE

Laser ablation of focal lesions in patients with medically refractory partial epilepsy.

Interventions

Laser ablation

Laser ablation of focal lesions in patients with medically refractory partial epilepsy.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

W. Richard Marsh

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

W Marsh, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

10-007909

Identifier Type: -

Identifier Source: org_study_id