Clinical Evaluation of the Effectiveness and Safety of Vagus Nerve Stimulation for Tuberous Sclerosis Complex Related Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- % of patients with Mchugh grading
研究概览
简要总结
Prospective cohort studies to identify clinical epilepsy control, cognitive changes, and safety of VNS in patients with tuberous sclerosis complex-related epilepsy.
详细描述
This study aims to evaluate the efficacy and safety of vagus nerve stimulation (VNS) in the treatment of drug-resistant epilepsy in patients with Tuberous Sclerosis Complex (TSC) and compare it with traditional antiepileptic drug therapy. By assessing seizure frequency, severity, and improvements in quality of life, the study seeks to provide evidence-based guidance for clinical treatment strategies.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age Range: Patients aged 1 to 18 years.
- •Confirmed Diagnosis: Diagnosed with Tuberous Sclerosis Complex (TSC) according to established diagnostic criteria.
- •Drug-Resistant Epilepsy: Ineffectiveness of at least two antiepileptic drugs (monotherapy or combination therapy).
- •Informed Consent: Patients and their guardians understand the purpose of the study and voluntarily sign the informed consent form.
- •Exclusion Criteria：
- •Other Severe Diseases: Presence of significant cardiovascular, respiratory, or other systemic diseases.
- •Psychiatric Disorders: History or presence of severe psychiatric disorders (e.g., schizophrenia or major depressive disorder).
- •Surgical Contraindications: Unsuitability for general anesthesia or factors affecting surgical safety.
- •Drug Allergy: Known allergy to drugs used in the study.
- •Implant Conflict: Presence of implanted medical devices that may interfere with VNS therapy.
- •Pregnancy or Lactation: Pregnant or breastfeeding individuals.
- •Poor Compliance: Inability to adhere to follow-up visits or treatment protocols.
排除标准
- 未提供
结局指标
主要结局
% of patients with Mchugh grading
时间窗: 4 years
The grading made by Mchugh for the classification of outcome with respect to epileptic seizures following epilepsy surgery. It contains a total of 5 levels. The higher the level, the worse the result. We will count the percentage of patients at each level.epileptic seizures following epilepsy surgery. It is used for assessing the control of epilepsy.
次要结局
- IQ(3 years)
- Quality of Life: QOLIE-31(3 years)
研究者
Shuli Liang
Director of Functional Neurosurgery
Beijing Children's Hospital