Stereotactic-EEG Guided Radio-frequency Thermocoagulation Versus Anterior Temporal Lobectomy for Mesial Temporal Lobe Epilepsy With Hippocampus Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Cognitive function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Cognitive function
时间窗: 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.
次要结局
- 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)