SEEG Guided RF-TC v.s. ATL for mTLE With HS

Study Overview
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Brief Summary
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Mesial temporal lobe epilepsy (mTLE) is the most classical subtype of temporal lobe epilepsy, which is the indication of surgical intervention after evaluation. Until now, anterior temporal lobectomy (ATL) is still the recommended treatment for mTLE. However, evidences are accumulated including post ATL tetartanopia and memory deterioration and new minimized invasive treatments are introduced. Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) is one of the option with lower seizure freedom but with higher neurological function reservation. This study is aiming at comparison of the efficacy and safety between SEEG guided RF-TC and classical ATL in the treatment of mTLE.

Detailed Description
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Nowadays, more and more patients received SEEG implantation for the evaluation of intractable seizures. SEEG is not only a diagnostic method to locate the origin of the epileptic seizures but also a media to treat or to cure this disease. Using radiofrequency thermocoagulation, we are able to coagulate some part of the brain guided by SEEG. However, until now, we don't have high level evidence for the efficacy and safety of RF-TC. In our resent series, we found the 1 year seizure free rate of mTLE patients after RF-TC is about 80% without any notable complication. In this trail, we will compare the efficacy as well as the safety of anterior temporal lobectomy with RF-TC for the mTLE patients, including the 1 year Engel class, perioperative complications, cognitive function, visual field, etc. Thus we can provide more high level evidence on the usage of SEEG guided RF-TC on mTLE patients.

Official Title
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Stereotactic-EEG Guided Radio-frequency Thermocoagulation Versus Anterior Temporal Lobectomy for Mesial Temporal Lobe Epilepsy With Hippocampus Sclerosis

Conditions
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Epilepsy, Temporal Lobe

Intervention / Treatment
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* Procedure: SEEG guided RF-TC
* Procedure: Anterior temporal lobectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of drug resistant epilepsy At least one or more anti-epileptic drugs (AEDs) regular administered for more than 2 years, one of which was either Dilantin, Tegretol, Carbatrol, or Trileptal used in appropriate doses, have failed due to inefficacy, not intolerance Persistence of disabling seizures at least 3 times per 3 months or greater, and once or more in recent 1 month 14 years or older at enrollment Simple and complex partial seizures, with or without secondarily generalized seizures beginning in childhood or later, with or without febrile convulsions earlier Auras that occur in isolation and are not primary sensory other than olfactory or gustatory I.Q. of greater than 70 Hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging Interictal EEG shows focal or lateralized spikes on temporal, frontal zone, or sphenoid electrode Ictal EEG onset is focal or lateralized on the ipsilateral side Ipsilateral temporal focal hypometabolism on PET Must be agreed by a consensus of ipsilateral mesial temporal origin by a multidisciplinary discussion Must be able to understand and speak Mandarin Exclusion criteria: A history of serious cerebral insult after the age of 5 A progressive neurological disorder; mental retardation (I.Q. less than 70) Psychogenic seizures Focal neurological deficits other than memory disturbances Any unexplained focal or lateralized neurological deficits other than memory dysfunction. Temporal neocortical or extratemporal lesions on MRI Psychosis, current or recent substance abuse, suicidality, anorexia, or psychogenic seizures Severe systemic diseases Unequivocal focal extratemporal EEG slowing or interictal spikes Lesions on MRI outside of the mesial temporal area Diffuse unilateral or bilateral hypometabolism on positron emission tomography (PET) Contralateral or extratemporal ictal onset Persistent extratemporal, or predominant contralateral focal interictal spikes or slowing, or generalized interictal spikes Patient who was included in any clinical trial Pregnancy

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anterior temporal lobectomy<br>surgical treatment for mTLE | Procedure: Anterior temporal lobectomy<br>* classical surgical treatment for mesial temporal lobe epilepsy, including the resection of neocortex for 5.5cm in non dominant hemisphere or 4.5cm in dominant hemisphere<br>|
| Active Comparator: SEEG guided RF-TC<br>SEEG recording and minimal invasive treatment for mTLE | Procedure: SEEG guided RF-TC<br>* SEEG implantation after evaluation, record the interictal and ictal EEG, and perform RF-TC after the localization confirmation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function | Full scaled Wechsler Adult Intelligence Quality IV Chinese edition (WAIS-IV-C), or Wechsler Children Intelligence Quality IV Chinese edition (WCIS-IV-C) Higher values represent a better outcome. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure freedom | Engel classification at 1 year | 1 year | 
| Visual field | Visual field examination | 1 year | 
| Number of participants with procedure related complications | Postoperative stroke with or without symptoms (by MRI); Postoperative intracranial bleeding with or without symptoms (by MRI); Postoperative intracranial infection; Postoperative wound infection; Postoperative subcutaneous dropsy. | 1 year | 
| Quality of life after treatment | Quality of Life in Epilepsy 89 (QOLIE-89) for adults (aged from 17-60), and Quality of Life in Epilepsy 89 (QOLIE-48) for children (aged from 14-16) | 1 year | 
| Average hospitalization expenses | Whole expenses of each group of patients | 1 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temporal lobe epilepsy; hippocampus sclerosis (HS); radiofrequency thermocoagulation (RF-TC); cognitive status