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

• Published in: Current controlled trials in cardiovascular medicine Vol. 22; no. 1; p. 425
• Main Authors: Wang, Yi-He, Chen, Si-Chang, Wei, Peng-Hu, Yang, Kun, Fan, Xiao-Tong, Meng, Fei, Du, Jia-Lin, Ren, Lian-Kun, Shan, Yong-Zhi, Zhao, Guo-Guang
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 29.06.2021; BioMed Central; BMC
• Subjects: Ablation; Anterior Temporal Lobectomy; Care and treatment; Child, Preschool; Clinical trials; Cognitive ability; Comparative analysis; Complications and side effects; Convulsions & seizures; Diagnosis; Drug resistance; Electrocoagulation - adverse effects; Electrodes; Electroencephalography; Epilepsy; Epilepsy, Temporal Lobe - diagnosis; Epilepsy, Temporal Lobe - pathology; Epilepsy, Temporal Lobe - surgery; Hippocampus - pathology; Hippocampus - surgery; Humans; Magnetic resonance imaging; Memory; Mesial temporal lobe epilepsy; Quality of Life; Radiofrequency ablation; Randomised controlled trial; Randomized Controlled Trials as Topic; Sclerosis - pathology; Stereotatic electroencephalograph (SEEG)-guided radiofrequency thermocoagulation (RF-TC); Study Protocol; Temporal lobe epilepsy; Thoracic surgery; Treatment Outcome; China; Mesial temporal lobe epilepsy; Randomised controlled trial; Stereotatic electroencephalograph (SEEG)-guided radiofrequency thermocoagulation (RF-TC)
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-021-05378-3

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. 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. 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. 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.