SEEG Guided RF-TC v.s. ATL for mTLE With HS (STARTS)
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About
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.
Full description
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.
Enrollment
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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
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Trial design
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40 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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