Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refr… (NCT01703143) | Clinical Trial Compass
CompletedPhase 1
Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy
United States14 participantsStarted 2011-05
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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