Back to resultsPilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Laser ablation
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility 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
Sites / Locations
- Mayo Clinic in Florida
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laser Ablation
Arm Description
Laser ablation of focal lesions in patients with medically refractory partial epilepsy.
Outcomes
Primary Outcome Measures
The number of seizures recorded in seizure diary
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01703143
Brief Title
Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy
Official Title
A Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser Ablation
Arm Type
Experimental
Arm Description
Laser ablation of focal lesions in patients with medically refractory partial epilepsy.
Intervention Type
Procedure
Intervention Name(s)
Laser ablation
Intervention Description
Laser ablation of focal lesions in patients with medically refractory partial epilepsy.
Primary Outcome Measure Information:
Title
The number of seizures recorded in seizure diary
Time Frame
Baseline to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W Marsh, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy
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