Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Patients With Drug-resistant Epilepsy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Seizure-freedom rate
研究概览
简要总结
The goal of the real-world study is to evaluate the long-term seizure control outcomes, postoperative complications, long term impact on cognitive, memory function outcomes, quality-of-life measures, and healthcare resource utilization of magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) on patients with drug-resistant epilepsy (DRE).
详细描述
Epilepsy, a complex neurological disorder characterized by recurrent seizures, affects millions of individuals worldwide, challenging both patients and healthcare providers. The main indication for the epilepsy surgery is the drug resistance as per the consensus from the Task Force of the International League Against Epilepsy (ILAE). Traditional open surgery is an established treatment for drug-resistant epilepsy (DRE), but has limitations such as invasiveness and long recovery times. With the significant advancements of technology, the minimally invasive therapeutic approaches have emerged, among which Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) stands out as a promising intervention. It provides targeted ablation of epileptogenic tissue while preserving healthy brain regions. Understanding MRgLITT's comprehensive value for DRE is of increasing interest.
This real-world study aims to comprehensively evaluate the clinical outcomes, safety profiles, and cost-effectiveness of MRgLITT in patients with DRE. The results of this clinical trial protocol are expected to serve as a comprehensive guide for researchers, clinicians, and stakeholders interested in the treatment of DRE using MRgLITT. We believe this study can influence future treatment strategies, leading to improved outcomes and enhanced quality of life for individuals with epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 12 and 75 (provided that rigorous prior studies have been done to suggest appropriate dosing for ages 12 and above);
- •Patients or the assents are able to provide informed consent;
- •Ability to keep accurate seizure diaries;
- •Complete presurgical evaluation information;
- •Meets the 2009 ILAE definition of DRE (Failure of adequate trials of two tolerated and appropriately chosen and used AED schedules (whether as monotherapy or in combination) to achieve sustained seizure freedom) ;
排除标准
- •Subjects with significant progressive disorders or unstable medical conditions requiring acute intervention;
- •Clinically relevant abnormalities in bloodwork detected (e.g., rising or new onset 3X liver function tests [LFTs]);
- •Active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt;
- •A psychiatric disorder where changes in pharmacotherapy are needed or anticipated during the study;
- •Diagnosed with intracranial space-occupying lesions or dual pathology by neuroimaging inspection;
- •Women who are pregnant, planning to become pregnant during the study period, or currently breastfeeding may be excluded due to the potential risks associated with surgery and anesthesia;
- •Patients with a history of previous brain surgery, including prior epilepsy surgery, that may interfere with the study objectives or confound the interpretation of results may be excluded;
- •Any condition that may impact a patient's ability to follow study procedures or patient's safety, based on what is known about the pharmacology/toxicology profile of the trial agent(s);
结局指标
主要结局
Seizure-freedom rate
时间窗: 6-month, 1-year and 2-year after surgery
Percentage
次要结局
- ILAE classification of outcome(6-month, 1-year and 2-year after surgery)
- Seizure severity(6-month, 1-year and 2-year after surgery)
- Rate of mild complications(Within 1 month after surgery)
- Rate of reoperations(6-month, 1-year and 2-year after surgery)
- Seizure frequency reduction(6-month, 1-year and 2-year after surgery)
- Cognitive function evaluation(6-month, 1-year and 2-year after surgery)
- Rate of antiepileptic drug reduction or withdrawn(6-month, 1-year and 2-year after surgery)
- Memory function evaluation(6-month, 1-year and 2-year after surgery)
- The quality of life(6-month, 1-year and 2-year after surgery)
- Length of hospital stay(Within 1 month after surgery)