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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703143
• Other study ID #: 10-007909
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2012
• Last updated: January 23, 2015
• Start date: May 2011
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of seizures recorded in seizure diary		Baseline to 1 year	Yes