{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T12:49:56Z","timestamp":1772110196021,"version":"3.50.1"},"reference-count":25,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,6,29]],"date-time":"2021-06-29T00:00:00Z","timestamp":1624924800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,6,29]],"date-time":"2021-06-29T00:00:00Z","timestamp":1624924800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["81871009"],"award-info":[{"award-number":["81871009"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["81801288"],"award-info":[{"award-number":["81801288"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Introduction<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods and analysis<\/jats:title>\n                <jats:p>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\u2009years 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03941613?cond=MTLE&amp;draw=2&amp;rank=4\">NCT03941613<\/jats:ext-link>. 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.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-021-05378-3","type":"journal-article","created":{"date-parts":[[2021,6,29]],"date-time":"2021-06-29T14:26:26Z","timestamp":1624976786000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Stereotactic EEG-guided radiofrequency thermocoagulation versus anterior temporal lobectomy for mesial temporal lobe epilepsy with hippocampal sclerosis: study protocol for a randomised controlled trial"],"prefix":"10.1186","volume":"22","author":[{"given":"Yi-He","family":"Wang","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Si-Chang","family":"Chen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peng-Hu","family":"Wei","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kun","family":"Yang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiao-Tong","family":"Fan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fei","family":"Meng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jia-Lin","family":"Du","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lian-Kun","family":"Ren","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yong-Zhi","family":"Shan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guo-Guang","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,6,29]]},"reference":[{"issue":"1","key":"5378_CR1","doi-asserted-by":"publisher","first-page":"14","DOI":"10.1212\/CPJ.0b013e31823d07d1","volume":"1","author":"GL Krauss","year":"2011","unstructured":"Krauss GL, Sperling MR. Treating patients with medically resistant epilepsy. Neurol Clin Pract. 2011;1(1):14\u201323. https:\/\/doi.org\/10.1212\/CPJ.0b013e31823d07d1.","journal-title":"Neurol Clin Pract"},{"issue":"5","key":"5378_CR2","doi-asserted-by":"publisher","first-page":"356","DOI":"10.1097\/WNP.0b013e31826b3ab7","volume":"29","author":"WO Tatum","year":"2012","unstructured":"Tatum WO. Mesial temporal lobe epilepsy. J Clin Neurophysiol. 2012;29(5):356\u201365. https:\/\/doi.org\/10.1097\/WNP.0b013e31826b3ab7.","journal-title":"J Clin Neurophysiol"},{"issue":"4","key":"5378_CR3","doi-asserted-by":"publisher","first-page":"340","DOI":"10.1177\/107385840100700410","volume":"7","author":"J Engel Jr","year":"2001","unstructured":"Engel J Jr. Mesial temporal lobe epilepsy: what have we learned? Neuroscientist. 2001;7(4):340\u201352. https:\/\/doi.org\/10.1177\/107385840100700410.","journal-title":"Neuroscientist"},{"issue":"5","key":"5378_CR4","doi-asserted-by":"publisher","first-page":"311","DOI":"10.1056\/NEJM200108023450501","volume":"345","author":"S Wiebe","year":"2001","unstructured":"Wiebe S, Blume WT, Girvin JP, Eliasziw M. A randomized, controlled trial of surgery for temporal-lobe epilepsy. N Engl J Med. 2001;345(5):311\u20138. https:\/\/doi.org\/10.1056\/NEJM200108023450501.","journal-title":"N Engl J Med"},{"key":"5378_CR5","doi-asserted-by":"publisher","unstructured":"W. S. Erkrankung des ammonshorns als aetiologisches moment der epilepsie. Arch Psychiatr Nervenkr 1880;10(3):631-675, DOI: https:\/\/doi.org\/10.1007\/BF02224538.","DOI":"10.1007\/BF02224538"},{"issue":"4","key":"5378_CR6","doi-asserted-by":"publisher","first-page":"491","DOI":"10.1001\/archneurpsyc.1950.02310280003001","volume":"64","author":"W Penfield","year":"1950","unstructured":"Penfield W, Flanigin H. Surgical therapy of temporal lobe seizures. AMA Arch Neurol Psychiatry. 1950;64(4):491\u2013500. https:\/\/doi.org\/10.1001\/archneurpsyc.1950.02310280003001.","journal-title":"AMA Arch Neurol Psychiatry"},{"issue":"10","key":"5378_CR7","doi-asserted-by":"publisher","first-page":"1978","DOI":"10.1111\/j.1528-1167.2010.02641.x","volume":"51","author":"J Engel Jr","year":"2010","unstructured":"Engel J Jr, McDermott MP, Wiebe S, et al. Design considerations for a multicenter randomized controlled trial of early surgery for mesial temporal lobe epilepsy. Epilepsia. 2010;51(10):1978\u201386. https:\/\/doi.org\/10.1111\/j.1528-1167.2010.02641.x.","journal-title":"Epilepsia"},{"issue":"3","key":"5378_CR8","doi-asserted-by":"publisher","DOI":"10.3171\/2011.12.FOCUS11342","volume":"32","author":"O Sagher","year":"2012","unstructured":"Sagher O, Thawani JP, Etame AB, Gomez-Hassan DM. Seizure outcomes and mesial resection volumes following selective amygdalohippocampectomy and temporal lobectomy. Neurosurg Focus. 2012;32(3):E8. https:\/\/doi.org\/10.3171\/2011.12.FOCUS11342.","journal-title":"Neurosurg Focus"},{"key":"5378_CR9","doi-asserted-by":"publisher","first-page":"62","DOI":"10.1016\/j.seizure.2018.10.017","volume":"63","author":"M Quigg","year":"2018","unstructured":"Quigg M, Barbaro NM, Ward MM, Chang EF, Broshek DK, Langfitt JT, et al. Visual field defects after radiosurgery versus temporal lobectomy for mesial temporal lobe epilepsy: findings of the ROSE trial. Seizure. 2018;63:62\u20137. https:\/\/doi.org\/10.1016\/j.seizure.2018.10.017.","journal-title":"Seizure"},{"issue":"8","key":"5378_CR10","doi-asserted-by":"publisher","first-page":"1473","DOI":"10.1111\/epi.13831","volume":"58","author":"B Mathon","year":"2017","unstructured":"Mathon B, Bielle F, Samson S, Plaisant O, Dupont S, Bertrand A, et al. Predictive factors of long-term outcomes of surgery for mesial temporal lobe epilepsy associated with hippocampal sclerosis. Epilepsia. 2017;58(8):1473\u201385. https:\/\/doi.org\/10.1111\/epi.13831.","journal-title":"Epilepsia"},{"key":"5378_CR11","doi-asserted-by":"publisher","first-page":"145","DOI":"10.1007\/978-3-7091-8592-6_18","volume":"30","author":"F Marossero","year":"1980","unstructured":"Marossero F, Ravagnati L, Sironi VA, et al. Late results of stereotactic radiofrequency lesions in epilepsy. Acta Neurochir Suppl (Wien). 1980;30:145\u20139. https:\/\/doi.org\/10.1007\/978-3-7091-8592-6_18.","journal-title":"Acta Neurochir Suppl (Wien)"},{"issue":"9","key":"5378_CR12","doi-asserted-by":"publisher","first-page":"1998","DOI":"10.1007\/s00415-018-8958-9","volume":"265","author":"A Moles","year":"2018","unstructured":"Moles A, Guenot M, Rheims S, et al. SEEG-guided radiofrequency coagulation (SEEG-guided RF-TC) versus anterior temporal lobectomy (ATL) in temporal lobe epilepsy. J Neurol. 2018;265(9):1998\u20132004. https:\/\/doi.org\/10.1007\/s00415-018-8958-9.","journal-title":"J Neurol"},{"key":"5378_CR13","doi-asserted-by":"publisher","unstructured":"Lee CY, Li HT, Wu T, et al. Efficacy of limited hippocampal radiofrequency thermocoagulation for mesial temporal lobe epilepsy. J Neurosurg. 2018;131(3):781\u20139. https:\/\/doi.org\/10.3171\/2018.4.JNS184.","DOI":"10.3171\/2018.4.JNS184"},{"issue":"6","key":"5378_CR14","doi-asserted-by":"publisher","first-page":"1358","DOI":"10.3171\/2014.12.JNS141968","volume":"123","author":"M Cossu","year":"2015","unstructured":"Cossu M, Fuschillo D, Casaceli G, Pelliccia V, Castana L, Mai R, et al. Stereoelectroencephalography-guided radiofrequency thermocoagulation in the epileptogenic zone: a retrospective study on 89 cases. J Neurosurg. 2015;123(6):1358\u201367. https:\/\/doi.org\/10.3171\/2014.12.JNS141968.","journal-title":"J Neurosurg"},{"issue":"1","key":"5378_CR15","doi-asserted-by":"publisher","first-page":"37","DOI":"10.3171\/2018.1.PEDS17435","volume":"22","author":"TJ Abel","year":"2018","unstructured":"Abel TJ, Varela Osorio R, Amorim-Leite R, Mathieu F, Kahane P, Minotti L, et al. Frameless robot-assisted stereoelectroencephalography in children: technical aspects and comparison with Talairach frame technique. J Neurosurg Pediatr. 2018;22(1):37\u201346. https:\/\/doi.org\/10.3171\/2018.1.PEDS17435.","journal-title":"J Neurosurg Pediatr"},{"key":"5378_CR16","doi-asserted-by":"publisher","first-page":"e1073","DOI":"10.1016\/j.wneu.2018.03.148","volume":"114","author":"PH Wei","year":"2018","unstructured":"Wei PH, An Y, Fan XT, Wang YH, Yang YF, Ren LK, et al. Stereoelectroencephalography-guided radiofrequency thermocoagulation for hypothalamic hamartomas: preliminary evidence. World Neurosurg. 2018;114:e1073\u2013e78. https:\/\/doi.org\/10.1016\/j.wneu.2018.03.148.","journal-title":"World Neurosurg"},{"key":"5378_CR17","doi-asserted-by":"publisher","first-page":"126","DOI":"10.1016\/j.eplepsyres.2017.08.011","volume":"142","author":"H Malikova","year":"2018","unstructured":"Malikova H, Liscak R. A neurosurgeon\u2019s view: outcome after RF-ablation for mTLE. Epilepsy Res. 2018;142:126\u201330. https:\/\/doi.org\/10.1016\/j.eplepsyres.2017.08.011.","journal-title":"Epilepsy Res"},{"issue":"12","key":"5378_CR18","doi-asserted-by":"publisher","first-page":"2296","DOI":"10.1111\/epi.14584","volume":"59","author":"P Bourdillon","year":"2018","unstructured":"Bourdillon P, Cucherat M, Isnard J, Ostrowsky-Coste K, Catenoix H, Gu\u00e9not M, et al. Stereo-electroencephalography-guided radiofrequency thermocoagulation in patients with focal epilepsy: a systematic review and meta-analysis. Epilepsia. 2018;59(12):2296\u2013304. https:\/\/doi.org\/10.1111\/epi.14584.","journal-title":"Epilepsia"},{"issue":"8","key":"5378_CR19","doi-asserted-by":"publisher","first-page":"1529","DOI":"10.1007\/s00701-014-2126-5","volume":"156","author":"Z Vojtech","year":"2014","unstructured":"Vojtech Z, Malikova H, Kramska L, et al. Long-term seizure outcome after stereotactic amygdalohippocampectomy. Acta Neurochir (Wien). 2014;156(8):1529\u201337. https:\/\/doi.org\/10.1007\/s00701-014-2126-5.","journal-title":"Acta Neurochir (Wien)"},{"key":"5378_CR20","doi-asserted-by":"publisher","first-page":"161","DOI":"10.1016\/j.eplepsyres.2017.08.017","volume":"142","author":"JA Witt","year":"2018","unstructured":"Witt JA, Hoppe C, Helmstaedter C. Neuropsychologist\u2019s (re-)view: resective versus ablative amygdalohippocampectomies. Epilepsy Res. 2018;142:161\u20136. https:\/\/doi.org\/10.1016\/j.eplepsyres.2017.08.017.","journal-title":"Epilepsy Res"},{"issue":"6","key":"5378_CR21","doi-asserted-by":"publisher","first-page":"372","DOI":"10.1159\/000366003","volume":"92","author":"H Malikova","year":"2014","unstructured":"Malikova H, Kramska L, Vojtech Z, Liscak R, Sroubek J, Lukavsky J, et al. Different surgical approaches for mesial temporal epilepsy: resection extent, seizure, and neuropsychological outcomes. Stereotact Funct Neurosurg. 2014;92(6):372\u201380. https:\/\/doi.org\/10.1159\/000366003.","journal-title":"Stereotact Funct Neurosurg"},{"issue":"3","key":"5378_CR22","doi-asserted-by":"publisher","first-page":"423","DOI":"10.1016\/j.eplepsyres.2013.07.009","volume":"106","author":"H Malikova","year":"2013","unstructured":"Malikova H, Kramska L, Vojtech Z, Lukavsky J, Liscak R. Stereotactic radiofrequency amygdalohippocampectomy: two years of good neuropsychological outcomes. Epilepsy Res. 2013;106(3):423\u201332. https:\/\/doi.org\/10.1016\/j.eplepsyres.2013.07.009.","journal-title":"Epilepsy Res"},{"issue":"Pt 5","key":"5378_CR23","doi-asserted-by":"publisher","first-page":"1188","DOI":"10.1093\/brain\/awh449","volume":"128","author":"JF Tellez-Zenteno","year":"2005","unstructured":"Tellez-Zenteno JF, Dhar R, Wiebe S. Long-term seizure outcomes following epilepsy surgery: a systematic review and meta-analysis. Brain. 2005;128(Pt 5):1188\u201398. https:\/\/doi.org\/10.1093\/brain\/awh449.","journal-title":"Brain"},{"issue":"5","key":"5378_CR24","doi-asserted-by":"publisher","first-page":"857","DOI":"10.1111\/j.1528-1167.2011.03022.x","volume":"52","author":"EM Sherman","year":"2011","unstructured":"Sherman EM, Wiebe S, Fay-McClymont TB, et al. Neuropsychological outcomes after epilepsy surgery: systematic review and pooled estimates. Epilepsia. 2011;52(5):857\u201369. https:\/\/doi.org\/10.1111\/j.1528-1167.2011.03022.x.","journal-title":"Epilepsia"},{"issue":"1","key":"5378_CR25","doi-asserted-by":"publisher","first-page":"15","DOI":"10.1016\/j.neucli.2017.11.006","volume":"48","author":"L Minotti","year":"2018","unstructured":"Minotti L, Montavont A, Scholly J, Tyvaert L, Taussig D. Indications and limits of stereoelectroencephalography (SEEG). Neurophysiol Clin. 2018;48(1):15\u201324. https:\/\/doi.org\/10.1016\/j.neucli.2017.11.006.","journal-title":"Neurophysiol Clin"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05378-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-021-05378-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05378-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,6,29]],"date-time":"2021-06-29T14:30:51Z","timestamp":1624977051000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-021-05378-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,6,29]]},"references-count":25,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["5378"],"URL":"https:\/\/doi.org\/10.1186\/s13063-021-05378-3","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,6,29]]},"assertion":[{"value":"3 April 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 June 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"29 June 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The STARTS protocol has been approved by the ethics committee at Xuanwu Hospital and will be conducted in accordance with the Declaration of Helsinki.Written informed consent will be obtained from all participants and their representatives. Beforehand, the participants and their representatives will receive the information about the nature and scope of the project in oral and written form by a member of the research team. In particular, all participants and their representatives will be informed about the benefit for her\/his health and potential risks.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"425"}}