SEEG Guided RF-TC v.s. ATL for mTLE With HS
Paraules clau
Resum
Descripció
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.
Dates
| Darrera verificació: | 10/31/2018 |
| Primer enviat: | 04/22/2019 |
| Inscripció estimada enviada: | 05/05/2019 |
| Publicat per primera vegada: | 05/07/2019 |
| Última actualització enviada: | 08/04/2019 |
| Publicació de l'última actualització: | 08/06/2019 |
| Data d'inici de l'estudi real: | 07/13/2019 |
| Data estimada de finalització primària: | 06/30/2021 |
| Data estimada de finalització de l’estudi: | 12/30/2021 |
Condició o malaltia
Intervenció / tractament
Procedure: SEEG guided RF-TC
Procedure: Anterior temporal lobectomy
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Experimental: Anterior temporal lobectomy surgical treatment for mTLE | Procedure: Anterior temporal lobectomy 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 |
| Active Comparator: SEEG guided RF-TC SEEG recording and minimal invasive treatment for mTLE | Procedure: SEEG guided RF-TC SEEG implantation after evaluation, record the interictal and ictal EEG, and perform RF-TC after the localization confirmation. |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 14 Years Per a 14 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | 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 |
Resultat
Mesures de resultats primaris
1. Cognitive function [1 year]
Mesures de resultats secundaris
1. Seizure freedom [1 year]
2. Visual field [1 year]
3. Number of participants with procedure related complications [1 year]
4. Quality of life after treatment [1 year]
5. Average hospitalization expenses [1 month after surgery]
