Stereotactic EEG-guided radiofrequency thermocoagulation versus anterior temporal lobectomy for mesial temporal lobe epilepsy with hippocampal sclerosis: study protocol for a randomised controlled trial

Abstract

Introduction In this report, we aim to describe the design for the randomised controlled trial of Stereotactic electroencephalogram (EEG)-guided Radiofrequency Thermocoagulation versus Anterior Temporal Lobectomy for Mesial Temporal Lobe Epilepsy with Hippocampal Sclerosis (STARTS). Mesial temporal lobe epilepsy (mTLE) is a classical subtype of temporal lobe epilepsy that often requires surgical intervention. Although anterior temporal lobectomy (ATL) remains the most popular treatment for mTLE, accumulating evidence has indicated that ATL can cause tetartanopia and memory impairments. Stereotactic EEG (SEEG)-guided radiofrequency thermocoagulation (RF-TC) is a non-invasive alternative associated with lower seizure freedom but greater preservation of neurological function. In the present study, we aim to compare the safety and efficacy of SEEG-guided RF-TC and classical ATL in the treatment of mTLE. Methods and analysis STARTS is a single-centre, two-arm, randomised controlled, parallel-group clinical trial. The study includes patients with typical mTLE over the age of 14 who have drug-resistant seizures for at least 2 years and have been determined via detailed evaluation to be surgical candidates prior to randomisation. The primary outcome measure is the cognitive function at the 1-year follow-up after treatment. Seizure outcomes, visual field abnormalities after surgery, quality of life, ancillary outcomes, and adverse events will also be evaluated at 1-year follow-up as secondary outcomes. Discussion SEEG-guided RF-TC for mTLE remains a controversial seizure outcome but has the advantage for cognitive and visual field protection. This is the first RCT studying cognitive outcomes and treatment results between SEEG-guided RF-TC and standard ATL for mTLE with hippocampal sclerosis. This study may provide higher levels of clinical evidence for the treatment of mTLE. Trial registration ClinicalTrials.gov NCT03941613. Registered on May 8, 2019. The STARTS protocol has been registered on the US National Institutes of Health. The status of the STARTS was recruiting and the estimated study completion date was December 31, 2021.

iTRAQ and PRM-Based Comparative Proteomic Profiling of the Hippocampus in Rat Models of Epilepsy

“…Epilepsy is a neurological disease involving limb twitching or nonconvulsive seizures triggered by abnormal firing of neurons in the brain. Many studies have shown that hippocampal plasticity is related to temporal lobe epilepsy [30,31]. Therefore, the hippocampus has been considered to be the most important region in the pathogenesis of temporal lobe epilepsy for many years.…”

Stereoelectroencephalography-Guided Radiofrequency Thermocoagulation: Diagnostic and Therapeutic Implications

“…When utilized in conjunction with careful SEEG implantation and analysis, RFT allows for direct lesioning of seizure onset zone. Currently, there are two active prospective clinical trials evaluating efficacy of SgRFTC; the first comparing SgRFTC to anterior temporal lobectomy in mesial temporal lobe epilepsy [74] and the second comparing SgRFTC to both MRgLITT and open resection across various focal epilepsies [75]. These prospective efforts, coupled with increased routine clinical utilization of SgRFTC, will not only further inform safety and efficacy but also elucidate novel applications.…”

Stereo‐electroencephalography‐guided three‐dimensional radiofrequency thermocoagulation for mesial temporal lobe epilepsy with hippocampal sclerosis: A retrospective study with long‐term follow‐up

“…Based on this approach, we conducted a study to determine whether patients experienced changes in cognitive function after surgery. 8 In 2019, we published the first clinical research report on the short‐term efficacy of SEEG‐3D RFTC in the treatment of patients with MTLE‐HS. 9 After 12 months of follow‐up, 16 patients (76.2%) presented Engel class I epilepsy, revealing that SEEG‐3D RFTC is effective in the treatment of drug‐refractory epilepsy and its curative effect is comparable to that of traditional craniotomy.…”

“…Thus, we can destroy the lesion while preserving the cognitive functions mapped by the corresponding leads. Based on this approach, we conducted a study to determine whether patients experienced changes in cognitive function after surgery 8 . In 2019, we published the first clinical research report on the short‐term efficacy of SEEG‐3D RFTC in the treatment of patients with MTLE‐HS 9 .…”