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

This study has been completed.
Information provided by (Responsible Party):
W. Richard Marsh, Mayo Clinic Identifier:
First received: October 5, 2012
Last updated: January 23, 2015
Last verified: January 2015
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.

Condition Intervention Phase
Procedure: Laser ablation
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • The number of seizures recorded in seizure diary [ Time Frame: Baseline to 1 year ]

Enrollment: 14
Study Start Date: May 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01703143

United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: W Marsh, MD Mayo Clinic
  More Information

Responsible Party: W. Richard Marsh, Principle Investigator, Mayo Clinic Identifier: NCT01703143     History of Changes
Other Study ID Numbers: 10-007909
Study First Received: October 5, 2012
Last Updated: January 23, 2015

Additional relevant MeSH terms:
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on April 26, 2017