Exploring the Characteristics of Epileptogenic Foci in Drug-Resistant Epilepsy Using Multimodal Imaging Techniques: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The characteristics of hybrid imaging in patients with different types of refractory epilepsy.
研究概览
简要总结
Using multimodal imaging technology, this study aims to explore the characteristics of epileptogenic foci in patients with drug-resistant epilepsy and identify key network nodes (such as central nodes) to provide more assistance for the diagnosis of drug-resistant epilepsy.
详细描述
This study is a prospective observational cohort study. It prospectively recruited 50 patients with drug-resistant epilepsy from the Epilepsy Center of the Department of Neurology at Xijing Hospital, all aged 18 years or older. It collected general information and clinical baseline data such as magnetic resonance imaging; gathered multimodal imaging data once; analyzed the characteristics of epileptogenic foci in patients with drug-resistant epilepsy; and performed statistical analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years old;
- •Meet the 2010 International League Against Epilepsy (ILAE) diagnostic criteria for drug-resistant epilepsy;
- •Duration of epilepsy ≥2 years, with an average seizure frequency of ≥2 times per month in the 3 months prior to enrollment;
- •Adequate intake of two or more anti-epileptic drugs, with no intervention in the treatment plan during the trial period;
- •Capable of cooperating to complete treatment and related examination items; The patient and family fully understand and voluntarily sign the informed consent form.
排除标准
- •In a state of continuous epileptic seizures;
- •Complicated with severe infections, cerebrovascular diseases, malignant tumors, and other diseases, accompanied by severe dysfunction of the heart, liver, kidney, or other organs, or with mental disorders, or with uncorrectable hyperglycemia, or 3.patients on long-term use of corticosteroid medications;
- •4.Pregnant or lactating women; 5.Contraindications for PET, MR, EEG examinations; 6.Patients with examinations (with ferromagnetic metal implants in the body; high fever); 7.Participating in other clinical trials at the same time; 8.The patient or family withdraws the informed consent form.
结局指标
主要结局
The characteristics of hybrid imaging in patients with different types of refractory epilepsy.
时间窗: baseline
Based on PET-FMRI-EEG hybrid fusion technology, explore the brain network characteristics of epilepsy patients.PET detects areas of reduced glucose metabolism, using radioactive isotopes (such as 18F-labeled fluorodeoxyglucose) to reflect the glucose metabolism of brain tissue. Typically in epilepsy patients, areas of hypometabolism may indicate the presence of epileptic foci. By using fMRI or EEG data, the synchronization of activities between different brain regions is analyzed to understand the organization and functional connectivity patterns of the brain network.
The characteristics of PET, fMRI, and EEG indicators in patients with different types of intractable epilepsy.
时间窗: baseline
Using different data analysis methods to explore the characteristics of PET, fMRI, and EEG indicators in patients with various types of intractable epilepsy.The characteristics of the power spectrum of various EEG frequency bands (Delta, Theta, Alpha, Beta, Gamma waves) and brain functional connectivity.
次要结局
- Quality of Life in Epilepsy 31 (QOLIE-31)(baseline，4weeks)