Optimizing Brain Stimulation Parameters

Mayo Clinic1 个研究点分布在 1 个国家目标入组 30 人2020年10月20日

适应症Epilepsy; Seizure

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Epilepsy; Seizure
发起方: Mayo Clinic
入组人数: 30
试验地点: 1
主要终点: Seizure burden
状态: 招募中
最后更新: 6个月前

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2020年10月20日

结束日期

2028年9月1日

最后更新

6个月前

研究类型

Interventional

研究设计

Crossover

性别

All

研究者

发起方

Mayo Clinic

责任方

Principal Investigator

主要研究者

Brian N. Lundstrom

Principal Investigator

Mayo Clinic

入排标准

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)