Stereotactic Laser Ablation for Temporal Lobe Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 45
- 主要终点
- Incidence of Qualifying Adverse Events
研究概览
简要总结
The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE).
详细描述
The purpose of the study is to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for necrotization or coagulation of epileptogenic foci in patients with intractable mesial temporal lobe epilepsy.
The study will include approximately 150 adult patients with drug-resistant MTLE treated at selected epilepsy centers across the United States. After the Visualase procedure, patients will be followed for 12 months and evaluated for freedom from seizures, quality of life, adverse events, and neuropsychological outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of drug-resistant mesial temporal lobe epilepsy (MTLE)
- •If the subject has a vagus nerve stimulator (VNS), must have failed to achieve sustained seizure freedom with the VNS implanted for at least 6 months
- •On stable antiepileptic drugs (AEDs) (and/or stable VNS setting, if applicable) and compliant with medication use
- •An average of at least 1 complex partial or secondarily generalized seizure compatible with MTLE per month
- •Seizure symptoms and/or auras compatible with MTLE
- •Video EEG shows evidence of seizures from one temporal lobe consistent with MTLE
- •MRI has evidence consistent with mesial temporal lobe sclerosis
- •Willing and able to remain on stable AEDs (and stable VNS setting, if applicable) for 12 months following the Visualase procedure
- •Willing and able to comply with protocol requirements
- •Able to complete study assessments in English or Spanish language
排除标准
- •Unwilling or unable to sign the study informed consent form
- •Pregnant or intends to become pregnant during the course of the study
- •Currently implanted with a device contraindicating MRI
- •Progressive brain lesions and/or tumors not associated with epileptic disease state
- •History of previous intracranial surgery for treatment of epileptic seizures
- •Persistent extra-temporal or predominant contralateral focal interictal spikes or slowing, or generalized interictal spikes on EEG
- •Seizures with contralateral or extra-temporal ictal onset on EEG
- •Aura and/or ictal behavior suggest an extra-temporal focus
- •MRI evidence of epileptogenic, extra-temporal lesions, dual pathology in the temporal lobe, or contralateral hippocampal MRI increased signal and/or loss of architecture
- •If additional testing has been performed, results are discordant with the seizure focus scheduled for ablation
- •Non-compliance with AED requirements
- •Dementia or other progressive neurological disease
- •Unstable major psychiatric illness, psychogenic non-epileptic seizures, or medical illness that would contraindicate the Visualase procedure or affect the neuropsychological assessments
- •Participation in other research that may potentially interfere with SLATE endpoint(s)
- •Allergy to gadolinium
研究组 & 干预措施
Treatment
Visualase MRI-guided laser ablation procedure
干预措施: Visualase MRI-Guided Laser Ablation (Device)
结局指标
主要结局
Incidence of Qualifying Adverse Events
时间窗: 12 months
The incidence of qualifying device, procedure and/or anesthesia related adverse events. These events must also be moderate or severe and permanent for the following AEs: anxiety, aphasia, blurry vision, depression, diplopia, emotional lability, hemianopia, hemiparesis, memory impairment/difficulty, neurologic deficits, paralysis, psychological/psychiatric complications, quadrantanopia, sensory loss, sleep problems or insomnia. An exact 95% confidence interval (CI) will be calculated to determine if the upper bound of the CI for qualified AEs is less than 40%.
Seizure Freedom, Defined as Engel Classification of Postoperative Outcome Class I
时间窗: 12 months
Seizure freedom at 12 months following the Visualase procedure (starting at 30 days post-procedure through 365 days post procedure). Engel Class I: Free of disabling seizures includes subclasses: A. Completely seizure free since surgery, B. Nondisabling simple partial seizures only since surgery, D. Generalized convulsions with antiepileptic drugs (AED) discontinuation only. An exact 95% CI will be calculated to determine if the lower bound of the CI for seizure freedom at 12 months following the Visualase procedure will be greater than 43%. Multiple imputation was used if subject diary data was not compliant. Retreated subjects are treated as failures.
次要结局
- Seizure Freedom Compared to Historical Controls (Medical Therapy)(12 months)
- Seizure Freedom, Including Subjects Retreated With Visualase(12 months)
- Change in Boston Naming Test Scores(Baseline and 12 months)
- Change in Rey Auditory Verbal Learning Test Scores(Baseline and 12 months)
- Change in Quality of Life in Epilepsy (QOLIE-31) Scores(Baseline and 12 months)
- Change in SF-36 Mental Component Score(Baseline and 12 Months)
- Change in SF-36 Physical Component Score(Baseline and 12 Months)
- Seizure Freedom Compared to Historical Controls (Open Surgical Resection)(12 Months)