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

Yi-He Wang, Si-Chang Chen, Peng-Hu Wei, Kun Yang, Xiao-Tong Fan, Fei Meng, Jia-Lin Du, Lian-Kun Ren, Yong-Zhi Shan, Guo-Guang Zhao, Yi-He Wang, Si-Chang Chen, Peng-Hu Wei, Kun Yang, Xiao-Tong Fan, Fei Meng, Jia-Lin Du, Lian-Kun Ren, Yong-Zhi Shan, Guo-Guang Zhao

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.

Keywords: Mesial temporal lobe epilepsy; Randomised controlled trial; Stereotatic electroencephalograph (SEEG)-guided radiofrequency thermocoagulation (RF-TC).

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Timeline of the STARTS protocol. Patients assigned to the ATL group will undergo ATL directly. Patients assigned to the RF-TC group will undergo SEEG implantation and monitoring until the first seizure episode. Then, 3D-crossing RF-TC will be conducted
Fig. 2
Fig. 2
A, B The distribution of SEEG electrodes via three-dimensional reconstruction and the relationship between electrodes and the mesial temporal area. OH, T, TH, and TB were implanted in the hippocampus. TA was implanted in the amygdala. C The combination of preoperative T1-weighted images and postoperative CT images. The relative anatomical position of the SEEG electrodes and brain structure can be observed. D Postoperative T2-weighted MRIs obtained within 1 week of SEEG-guided RF-TC

References

    1. Krauss GL, Sperling MR. Treating patients with medically resistant epilepsy. Neurol Clin Pract. 2011;1(1):14–23. doi: 10.1212/CPJ.0b013e31823d07d1.
    1. Tatum WO. Mesial temporal lobe epilepsy. J Clin Neurophysiol. 2012;29(5):356–365. doi: 10.1097/WNP.0b013e31826b3ab7.
    1. Engel J., Jr Mesial temporal lobe epilepsy: what have we learned? Neuroscientist. 2001;7(4):340–352. doi: 10.1177/107385840100700410.
    1. 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):311–318. doi: 10.1056/NEJM200108023450501.
    1. W. S. Erkrankung des ammonshorns als aetiologisches moment der epilepsie. Arch Psychiatr Nervenkr 1880;10(3):631-675, DOI: 10.1007/BF02224538.
    1. Penfield W, Flanigin H. Surgical therapy of temporal lobe seizures. AMA Arch Neurol Psychiatry. 1950;64(4):491–500. doi: 10.1001/archneurpsyc.1950.02310280003001.
    1. 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):1978–1986. doi: 10.1111/j.1528-1167.2010.02641.x.
    1. 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. doi: 10.3171/2011.12.FOCUS11342.
    1. Quigg M, Barbaro NM, Ward MM, Chang EF, Broshek DK, Langfitt JT, Yan G, Laxer KD, Cole AJ, Sneed PK, Hess CP, Yu W, Newman SA, Mueller S, Tripathi M, Heck CN, Miller JW, Garcia PA, McEvoy A, Fountain NB, Salanova V, Knowlton RC, Bagić A, Henry T, Kapoor S, McKhann G, Palade AE, Reuber M, Tecoma E. Visual field defects after radiosurgery versus temporal lobectomy for mesial temporal lobe epilepsy: findings of the ROSE trial. Seizure. 2018;63:62–67. doi: 10.1016/j.seizure.2018.10.017.
    1. Mathon B, Bielle F, Samson S, Plaisant O, Dupont S, Bertrand A, Miles R, Nguyen-Michel VH, Lambrecq V, Calderon-Garcidueñas AL, Duyckaerts C, Carpentier A, Baulac M, Cornu P, Adam C, Clemenceau S, Navarro V. Predictive factors of long-term outcomes of surgery for mesial temporal lobe epilepsy associated with hippocampal sclerosis. Epilepsia. 2017;58(8):1473–1485. doi: 10.1111/epi.13831.
    1. Marossero F, Ravagnati L, Sironi VA, et al. Late results of stereotactic radiofrequency lesions in epilepsy. Acta Neurochir Suppl (Wien) 1980;30:145–149. doi: 10.1007/978-3-7091-8592-6_18.
    1. 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):1998–2004. doi: 10.1007/s00415-018-8958-9.
    1. Lee CY, Li HT, Wu T, et al. Efficacy of limited hippocampal radiofrequency thermocoagulation for mesial temporal lobe epilepsy. J Neurosurg. 2018;131(3):781–9. 10.3171/2018.4.JNS184.
    1. Cossu M, Fuschillo D, Casaceli G, Pelliccia V, Castana L, Mai R, Francione S, Sartori I, Gozzo F, Nobili L, Tassi L, Cardinale F, Lo Russo G. Stereoelectroencephalography-guided radiofrequency thermocoagulation in the epileptogenic zone: a retrospective study on 89 cases. J Neurosurg. 2015;123(6):1358–1367. doi: 10.3171/2014.12.JNS141968.
    1. Abel TJ, Varela Osorio R, Amorim-Leite R, Mathieu F, Kahane P, Minotti L, Hoffmann D, Chabardes S. Frameless robot-assisted stereoelectroencephalography in children: technical aspects and comparison with Talairach frame technique. J Neurosurg Pediatr. 2018;22(1):37–46. doi: 10.3171/2018.1.PEDS17435.
    1. Wei PH, An Y, Fan XT, Wang YH, Yang YF, Ren LK, Shan YZ, Zhao GG. Stereoelectroencephalography-guided radiofrequency thermocoagulation for hypothalamic hamartomas: preliminary evidence. World Neurosurg. 2018;114:e1073–e1e78. doi: 10.1016/j.wneu.2018.03.148.
    1. Malikova H, Liscak R. A neurosurgeon’s view: outcome after RF-ablation for mTLE. Epilepsy Res. 2018;142:126–130. doi: 10.1016/j.eplepsyres.2017.08.011.
    1. Bourdillon P, Cucherat M, Isnard J, Ostrowsky-Coste K, Catenoix H, Guénot M, Rheims S. Stereo-electroencephalography-guided radiofrequency thermocoagulation in patients with focal epilepsy: a systematic review and meta-analysis. Epilepsia. 2018;59(12):2296–2304. doi: 10.1111/epi.14584.
    1. Vojtech Z, Malikova H, Kramska L, et al. Long-term seizure outcome after stereotactic amygdalohippocampectomy. Acta Neurochir (Wien) 2014;156(8):1529–1537. doi: 10.1007/s00701-014-2126-5.
    1. Witt JA, Hoppe C, Helmstaedter C. Neuropsychologist’s (re-)view: resective versus ablative amygdalohippocampectomies. Epilepsy Res. 2018;142:161–166. doi: 10.1016/j.eplepsyres.2017.08.017.
    1. Malikova H, Kramska L, Vojtech Z, Liscak R, Sroubek J, Lukavsky J, Druga R. Different surgical approaches for mesial temporal epilepsy: resection extent, seizure, and neuropsychological outcomes. Stereotact Funct Neurosurg. 2014;92(6):372–380. doi: 10.1159/000366003.
    1. Malikova H, Kramska L, Vojtech Z, Lukavsky J, Liscak R. Stereotactic radiofrequency amygdalohippocampectomy: two years of good neuropsychological outcomes. Epilepsy Res. 2013;106(3):423–432. doi: 10.1016/j.eplepsyres.2013.07.009.
    1. 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):1188–1198. doi: 10.1093/brain/awh449.
    1. Sherman EM, Wiebe S, Fay-McClymont TB, et al. Neuropsychological outcomes after epilepsy surgery: systematic review and pooled estimates. Epilepsia. 2011;52(5):857–869. doi: 10.1111/j.1528-1167.2011.03022.x.
    1. Minotti L, Montavont A, Scholly J, Tyvaert L, Taussig D. Indications and limits of stereoelectroencephalography (SEEG) Neurophysiol Clin. 2018;48(1):15–24. doi: 10.1016/j.neucli.2017.11.006.

Source: PubMed

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