Stereotactic-EEG Guided Radio-frequency Thermocoagulation Versus Anterior Temporal Lobectomy for Mesial Temporal Lobe Epilepsy With Hippocampus Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Epilepsy, Temporal Lobe
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Cognitive function
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Cognitive function
Time Frame: 1 year
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.
Secondary Outcomes
- Average hospitalization expenses(1 month after surgery)
- Seizure freedom(1 year)
- Visual field(1 year)
- Number of participants with procedure related complications(1 year)
- Quality of life after treatment(1 year)