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

January 23, 2015 updated by: W. Richard Marsh, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser Ablation
Laser ablation of focal lesions in patients with medically refractory partial epilepsy.
Procedure: Laser ablation
Laser ablation of focal lesions in patients with medically refractory partial epilepsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of seizures recorded in seizure diary
Time Frame: Baseline to 1 year
Baseline to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: W Marsh, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

October 5, 2012

First Submitted That Met QC Criteria

October 5, 2012

First Posted (Estimate)

October 10, 2012

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 23, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-007909

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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