SEEG Guided RF-TC v.s. ATL for mTLE With HS (STARTS)
Epilepsy, Temporal Lobe
About this trial
This is an interventional treatment trial for Epilepsy, Temporal Lobe focused on measuring temporal lobe epilepsy; hippocampus sclerosis (HS); radiofrequency thermocoagulation (RF-TC); cognitive status
Eligibility Criteria
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
Sites / Locations
- Xuanwu Hospital, Capital Medical University.
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Anterior temporal lobectomy
SEEG guided RF-TC
surgical treatment for mTLE
SEEG recording and minimal invasive treatment for mTLE