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

Completed · Phase 1

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT01703143

Run by

Mayo Clinic

People needed

14

Starts

2011-05-01

Expected to finish

2015-01-01

Last updated by the study team

2015-01-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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