Centromedian Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- McHugh Scale for outcome measure after Vagal Nerve Stimulation
研究概览
简要总结
Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Control Trial
详细描述
To directly compare the effectiveness and safety of deep brain stimulation (DBS) vs. vagus nerve stimulation (VNS) in children with drug-resistant epilepsy (DRE) or epileptic spasms.
This will be an open, non-blinded randomized control trial. Twenty (20) patients will be recruited and enrolled in this pilot study from SickKids.
Expected study duration is 36-48 months.
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
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or Male patients 5 years of age and over (17 and 11 months), not including 18 years old
- •Diagnosis of drug-resistant epilepsy with failure after trial of two anti-epileptic
- •Medications (as defined by Kwan et al. 20093). All children screened for entry into the study will be re-diagnosed by a neurologist prior to entry.
- •Main seizure type includes epileptic spasms and tonic spasms, as confirmed by electroencephalography.
- •Parents or legal guardians, including caregivers, are informed and able to give written consent.
- •Ability to comply with all testing, follow-ups and study appointments and protocols for 12 months following the end of the duration of the study
排除标准
- •Substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
- •Any contraindication to MRI scanning. A preoperative MRI scan is essential to
- •Planning DBS and therefore any contraindication to MRI is a contraindication to enrollment in the study.
- •Unwillingness or inability to return to SickKids for follow-up visits.
- •Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that will result in significant risk from a surgical procedure.
- •Pregnancy
- •Inability to communicate adequately in English in order to complete the baseline and follow-up questionnaires.
- •A co-morbid condition that requires frequent MRI scanning as part of the patient's regular care.
结局指标
主要结局
McHugh Scale for outcome measure after Vagal Nerve Stimulation
时间窗: 1 year
The McHugh Scale is a system used by doctors to assess how much a patient's seizures have improved after receiving Vagal Nerve Stimulation (VNS) therapy. Similar to the Engel Scale for epilepsy surgery, it categorizes outcomes into different classes based on the percentage reduction in seizure frequency, helping to standardize the evaluation of VNS treatment effectiveness.
Engel Epilepsy Surgery Outcome Scale
时间窗: 1 year
The Engel Epilepsy Surgery Outcome Scale is a common way doctors classify how well epilepsy surgery worked for a patient. It uses different classes (I, II, III, IV) to describe the reduction in seizures after surgery, ranging from being completely seizure-free to having no worthwhile improvement. Class I: Seizure-free Class II: Rare seizures Class III: Significant improvement but not seizure-free Class IV: No improvement or worse
ILAE Classification
时间窗: 1 year
he ILAE Classification is a standardized system used by doctors worldwide to precisely describe and categorize seizures and epilepsy. It helps them understand where a seizure starts in the brain, if a person's awareness is affected, and what symptoms occur, which then guides the best treatment plan.
Quality of Life in Childhood Epilepsy Questionnaire (QOLCE)
时间窗: 1 year
The QOLCE is designed to evaluate the health-related quality of life specifically in children with epilepsy, covering various aspects impacted by their condition.
次要结局
- Hague Seizure Severity Scale (HASS) - parent-perception scale(1 year)
- Seizure Severity Questionnaire (SSQ)(1 year)
- CarerQoL - measure of caregiver quality of life(1 year)
- Pediatric Quality of Life Inventory (PedsQL)(1 year)
- The Child Health Utility 9D (CHU9D)(1 year)
研究者
George Ibrahim
Staff Neurosurgeon
The Hospital for Sick Children