VNS Algorithm for Advanced Dosing
VNS Algorithm for Advanced Dosing: Example Guided Mode Titrations "The Augusta Way"
The goal of this clinical trial is to compare the standard programming of the VNS device (Control) to a modified programming (Augusta Way) in adults with epilepsy. The main question it aims to answer is:
Does the modified programming of the VNS reduce seizures faster than the standard programming?
Participants in both groups will:
- Attend up to 3 study visits every 3 months for 2 years
- Answer questionnaires to assess quality of life and cognitive function
- Maintain a diary of seizure activity
研究概览
详细说明
Little has changed in the last 10 years or more in regard to Vagus nerve stimulator (VNS) therapy programming parameters despite new technological advances. The goal of our study is to provide a comprehensive VNS dosing protocol which VNS programmers can refer to as the standard care of treatment escalation in patients with drug refectory epilepsy. Given the lack of newly published data regarding VNS system parameters, this study will allow epileptologists, general neurologists and neurosurgeons alike, access to an updated reference and model of VNS parameter escalation and treatment.
The investigators at Augusta University have developed a programming paradigm that appears to provide good clinical outcomes for VNS patients. The study will provide a comprehensive assessment of an experimental group ("the Augusta Way") programmed with a modified, more rapid titration paradigm developed at our site vs. "best clinical practice" (standard titration paradigm) control group of patients with VNS devices. The patients will be followed for at least 24 months post implantation. The study will assess safety of the new programming paradigm and will assess efficacy based upon seizure outcomes.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Brandy Quarles, MPH
- 电话号码:706-721-0390
- 邮箱:bquarles@augusta.edu
学习地点
-
-
Georgia
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Augusta、Georgia、美国、30912
- 招聘中
- Wellstar MCG Hospital
-
接触:
- Brandy Quarles, MPH
- 电话号码:7067210390
- 邮箱:bquarles@augusta.edu
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Subjects who are clinically determined to be candidates for VNS implantation for seizure control
- Subject/legally authorized representative able to provide informed consent.
Exclusion Criteria:
- Subjects with VNS system treating pathologies other than drug refractory epilepsy or medical co-morbidities that prevent any surgical intervention
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Augusta Way
Modified programming of VNS that provides rapid titration
|
Modified programming of VNS that provides rapid titration
|
|
有源比较器:Control
Standard of care VNS programming
|
Standard of Care VNS programming
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Seizure Diary
大体时间:From enrollment to end of participation at 2 years
|
A seizure diary is a personalized log used to record seizure activity, medication adherence, and potential triggers
|
From enrollment to end of participation at 2 years
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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