NCT06720922招募中不适用
Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Mesial Temporal Lobe Epilepsy: A Prospective, Randomized, Open Blinded, End-point Trial
Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年7月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Seizure freedom rate
研究概览
简要总结
How does magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) impact clinical prognosis in mesial temporal lobe epilepsy (mTLE)?
详细描述
- Compare the clinical prognosis between magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) and traditional open surgery (OS) on patients with mesial temporal lobe epilepsy (mTLE).
- Explore the factors associated with seizure outcomes.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years.
- •Drug-resistant mesial temporal lobe epilepsy.
- •Seizure frequency ≥ 1 time /month.
- •Participants approved.
排除标准
- •History of brain surgery.
- •Intracranial space occupying lesions.
- •Individuals with significant medical comorbidities or conditions that pose an excessive risk for surgery, such as severe cardiovascular disease, respiratory disorders, or uncontrolled systemic infections.
结局指标
主要结局
Seizure freedom rate
时间窗: 6-month, 1-year after surgery
According to International League Against Epilepsy \[ILAE\] Outcome Scale
次要结局
- Seizure frequency(6-month, 1-year after surgery)
- Seizure severity(6-month, 1-year after surgery)
- Cognitive function evaluation(6-month, 1-year after surgery)
- Memory function evaluation(6-month, 1-year after surgery)
- Quality of life for epilepsy patients(6-month, 1-year after surgery)
- Adverse events(within 7 days, 6-month, 1-year after surgery)
- Severe adverse events(within 7 days, 6-month, 1-year after surgery)
- Length of hospital stay(after surgery)
- Rate of antiepileptic drug reduction or withdrawn(1-year after surgery)
- Rate of reoperations(1-year after surgery)
- Seizure frequency(6-month, 1-year after surgery)
- Seizure severity(6-month, 1-year after surgery)
- Cognitive function evaluation(6-month, 1-year after surgery)
- Memory function evaluation(6-month, 1-year after surgery)
- Quality of life for epilepsy patients(6-month, 1-year after surgery)
- Adverse events(within 7 days, 6-month, 1-year after surgery)
- Severe adverse events(within 7 days, 6-month, 1-year after surgery)
- Length of hospital stay(after surgery)
- Rate of antiepileptic drug reduction or withdrawn(1-year after surgery)
- Rate of reoperations(1-year after surgery)
研究者
Kai Zhang
Dr.
Beijing Tiantan Hospital
研究点 (1)
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