Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients with Medically Refractory Partial Epilepsy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 10-007909
- Jacksonville, Florida: 10-007909
NCT ID: NCT01703143
Sponsor Protocol Number: VIS-10-005
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator W Marsh, M.D. |
Closed for enrollment |
|
Jacksonville, Fla.
Mayo Clinic principal investigator W Marsh, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available