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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
W. Richard Marsh, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01703143
First received: October 5, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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
Epilepsy
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: May 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703143

Locations
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Riann Boyd    904-953-7975    boyd.riann@mayo.edu   
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Karla Crockett    507-538-4880    crockett.karla@mayo.edu   
Principal Investigator: W Marsh, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: W Marsh, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: W. Richard Marsh, Principle Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01703143     History of Changes
Other Study ID Numbers: 10-007909
Study First Received: October 5, 2012
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014