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

Phase 1

Completed

• Conditions: Epilepsy
• Interventions: Procedure: Laser ablation

• Registration Number: NCT01703143
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-10-05
• Study First Submitted QC: 2012-10-05
• Study First Posted: 2012-10-10
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-23
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laser Ablation	Laser ablation	Laser ablation of focal lesions in patients with medically refractory partial epilepsy.

Primary Outcome Measures

Name	Time	Method
The number of seizures recorded in seizure diary	Baseline to 1 year

Trial Locations

Locations (2)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States