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Stereotactic Laser Ablation for Mesial Temporal Lobe Epilepsy: A prospective, multicenter, single‐arm study
Author(s) -
Sperling Michael R.,
Gross Robert E.,
Alvarez Guy E.,
McKhann Guy M.,
Salanova Vicenta,
Gilmore Julie
Publication year - 2020
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/epi.16529
Subject(s) - context (archaeology) , clinical endpoint , epilepsy , medicine , randomized controlled trial , adverse effect , ablation , clinical trial , temporal lobe , surgery , psychology , medical physics , psychiatry , paleontology , biology
Objective To describe the development of the Stereotactic Laser Ablation for Temporal Lobe Epilepsy study protocol in the context of current practice. An ideal treatment for drug‐resistant epilepsy remains an ongoing area of research. Although there are several options available, each has challenges that not only make deciding on the appropriate treatment not clear‐cut but also create difficulties in designing clinical studies to provide evidence in support of the treatment. Methods A prospective, single‐arm, multicenter study designed to evaluate safety and efficacy of the Visualase TM MRI‐Guided Laser Ablation System for the treatment of temporal lobe epilepsy will include up to 150 patients with a primary efficacy endpoint of seizure freedom (defined as Engel Class I) for the first 12 months following the procedure and a primary safety endpoint of incidence of qualifying device‐, procedure‐, or anesthesia‐related adverse events through 12 months following the procedure. Results Primary endpoints will be assessed against historical values of safety and efficacy of anterior temporal lobectomy. Significance The scientific and payor communities typically demand randomized controlled trials (RCTs) as definitive evidence for safety and efficacy claims. However, in circumstances where the medical device has already been cleared by regulatory authorities and is readily available in the market, an RCT may not be feasible to execute. It is therefore crucial to gain acceptance by both the scientific community and regulators to design a study that will satisfy all concerned.