Effect of Short-term Theta Frequency Stimulation of the Vagus Nerve on Cognition : a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 主要终点
- California Verbal and Learning Test 2nd edition group 3
研究概览
简要总结
The purpose of this investigation is data pilot study of the effect of theta frequency stimulation of the vagus nerve on cognitive performance in patients with refractory epilepsy. We will compare the effects of no stimulation, theta frequency (5 Hz), and 'standard' beta frequency stimulation (25-30 Hz) on cognitive measures. We hypothesize that theta frequency VNS will have a positive effect on memory retention. The goal of this study to provide initial data to inform the design of a larger clinical trial to examine the efficacy of theta VNS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Refractory Epilepsy
- •Previously implanted vagal nerve stimulator
- •Willingness and ability to undergo temporary changes to their VNS device settings
排除标准
- •<18 years of age
- •Adults unable to consent
- •Pregnant women
- •>20 on the Beck Depression Inventory (BDI)
- •<24 on the Montreal Cognitive Assessment (MOCA)
- •Adults with diagnosis of developmental delay, intellectual disability, or traumatic brain injury (TBI).
- •Adults with reported history of learning disability.
- •Adults unable to use a computer with their dominant hand.
- •Status Epilepticus within the past 6 months
结局指标
主要结局
California Verbal and Learning Test 2nd edition group 3
时间窗: hour 3
Test scored with lower values indicating worse memory and higher values indicating better memory. Minimum Value: -16 Maximum Value: 16
California Verbal and Learning Test 2nd edition group 2
时间窗: hour 2.25
Test scored with lower values indicating worse memory and higher values indicating better memory. Minimum Value: -16 Maximum Value: 16
California Verbal and Learning Test 2nd edition group 1
时间窗: hour 1.5
Test scored with lower values indicating worse memory and higher values indicating better memory. Minimum Value: -16 Maximum Value: 16
次要结局
未报告次要终点
研究者
Kiarash Shahlaie, M.D., Ph.D.
Associate Professor
University of California, Davis