Research on the Acute and Long Term Effects on Memory and the Mechanism of Action of Vagus Nerve Stimulation in Patients With Refractory Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Delayed recognition scores at session 1
研究概览
简要总结
Refractory epilepsy patients implanted with a vagus nerve stimulator perform a memory test at baseline in three conditions: invasive vagus nerve stimulation (VNS), transcutaneous vagus nerve stimulation (taVNS) and sham stimulation. After 6 weeks of VNS treatment, the memory test is repeated in two condition: invasive vagus nerve stimulation (VNS) and sham stimulation.
The endpoint of this experiment is assessing the effect of VNS and taVNS on memory performance.
详细描述
Previous studies underlined the potential of both invasive as transcutaneous auricular vagus nerve stimulation to ameliorate certain cognitive functions.
In this randomized, controlled cross-over within-subjects study, a memory test is conducted in patients with refractory epilepsy who are implanted with a vagus nerve stimulation.
The memory test consists out of a word recognition paradigm based on the study of Clarck et al. published in 1999 in Nature Neuroscience. Testing is performed at baseline (before start of the stimulation) and after 6 weeks of treatment with vagus nerve stimulation.
During the first session, the patients complete the word recognition task during three interventions:
- Invasive vagus nerve stimulation
- Transcutaneous vagus nerve stimulation (cymba concha)
- Sham vagus nerve stimulation (no stimulation)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Refractory epilepsy
- •Treated with vagus nerve stimulation
- •IQ >= 70 and able to perform the memory task
排除标准
- 未提供
结局指标
主要结局
Delayed recognition scores at session 1
时间窗: At baseline
Hitscore for correctly recognized target words (min score 0,max score 63, higher score indicates better performance), score for not recognized target words= misses (min score 0,max score 63, higher score indicates worse performance),correct rejection score of non-target related words (min score 0,max score 63, higher score indicates better performance), score for incorrect recognition of non-target related words= false alarms (min score 0,max score 63, higher score indicates worse performance), discrimination index= hit score -false alarm score (min score 0,max score 63, higher score indicates better performance). All scores are calculated as a percentage.
Delayed recognition scores at session 2
时间窗: After 6 weeks of VNS treatment
Hitscore for correctly recognized target words (min score 0,max score 48, higher score indicates better performance), score for not recognized target words= misses (min score 0,max score 48, higher score indicates worse performance),correct rejection score of non-target related words (min score 0,max score 48, higher score indicates better performance), score for incorrect recognition of non-target related words= false alarms (min score 0,max score 48, higher score indicates worse performance), discrimination index= hit score -false alarm score (min score 0,max score 48, higher score indicates better performance). All scores are calculated as a percentage.
Immediate recall score at session 1
时间窗: At baseline
Free recall score for correctly recalled words (min score 0,max score 21, higher score indicates better performance), calculated as a percentage
Immediate recall score at session 2
时间窗: After 6 weeks of VNS treatment
Free recall score for correctly recalled words (min score 0, max score 21, higher score indicates better performance)), calculated as a percentage
次要结局
- Attention score at session 2(After 6 weeks of VNS treatment)
- Attention score at session 1(At baseline)