NCT06617845招募中不适用
Optimizing Brain Stimulation Parameters
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Seizure burden
研究概览
简要总结
A primary purpose of this study is to better understand what stimulation parameters work best for patients. For example, for Deep Brain Stimulation (DBS) of the Anterior Nucleus of the Thalamus (ANT), it is not clear what stimulation frequency leads is most effective. This study will help assess the effectiveness of low frequency or high frequency stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are implanted with a brain stimulation device targeting the anterior nucleus of the thalamus per Mayo Clinic standard of care
排除标准
- •Patients for whom clinical follow-up is not expected during the initial 6-8 months following implant
结局指标
主要结局
Seizure burden
时间窗: Baseline, 4 months, 7 months, 12 months
Using the Mayo Epilepsy Short Assessment as well as patient diaries, seizure frequency is determined.
次要结局
- Change in Mayo Post-Stimulation Activation score(Baseline, 4 months, 7 months, 12 months)
- Change in Mayo Epilepsy Short Assessment (MESA) score(Baseline, 4 months, 7 months, 12 months)
研究者
Brian N. Lundstrom
Principal Investigator
Mayo Clinic
研究点 (2)
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