Effects of Recorded Music on Clinical and Electroencephalography (EEG) Seizure Activity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in the frequency of epileptiform discharges (number of seconds with spikes)
研究概览
简要总结
This research is being done to determine if Mozart music and/or age-appropriate music can reduce the frequency of seizures and epileptiform discharges.
详细描述
Several prospective studies have demonstrated the impact of Mozart's sonata for Two Pianos (K.448) on interictal epileptiform discharges and/or clinical seizure recurrence in children with epilepsy. While the exact mechanisms by which Mozart music has this effect are not yet established, there continues to be growing evidence demonstrating the positive effects on Mozart music upon seizure frequency and epileptiform discharges. Additional studies are needed to further elucidate the effect of Mozart music on epilepsy given the heterogeneity of protocols used in diverse clinical settings, with the goal of using these findings to drive potential therapy in the clinical setting.
Therefore, this study will explore if there are differences in epileptiform activity and clinical seizures between Mozart K.448, instrumental age-appropriate songs, and a patient's baseline activity during EMU stays. The children (age 4-17 yrs.) will listen to Mozart K.448 (1st movement) and instrumental age-appropriate songs with washout (10 minutes) in between, each lasting up to 9 minutes in the daytime. The music stimuli will be randomly played in 2 to 7 EMU stay days (average length of stay 4 days) and delivered via single-use earbuds. As per standard clinical care the investigators will monitor continuous video electroencephalography (EEG) in the epilepsy monitoring unit.
The frequency of epileptiform discharges (e.g., the number of spikes per 100 seconds, the number of seconds with spikes, and clinical seizures) will be counted before, during, and after music procedures. Heart rate variability and blood pressure will also be measured before, during, and after music stimuli to understand associations between physiological responses and epileptiform discharges to musical stimuli. Participants' behavior changes will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (age: 4 - 17 years old) who stay at Epilepsy Monitoring Units (EMU) up to 7 days may join.
排除标准
- •Non-English Speaking
研究组 & 干预措施
Children with Epilepsy
Children (age: 4- 17 years old) will participate in this study, and they will listen to Mozart K.448 (1st movement) and instrumental age-appropriate song with 10 minutes wash out in between, each lasting up to 9 minutes in the daytime (between 1-5 pm). The music stimuli will be randomly played in 2 to 7 days during the EMU stay (average 4 days). Music will be delivered via single-use earbuds.
干预措施: Music Stimuli (Behavioral)
结局指标
主要结局
Change in the frequency of epileptiform discharges (number of seconds with spikes)
时间窗: Epilepsy Monitoring Units Stay (up to Day 7)
The number of seconds with spikes will be measured.
Change in the frequency of epileptiform discharges (number of spikes)
时间窗: Epilepsy Monitoring Units Stay (up to Day 7)
The number of spikes in 100 seconds will be counted.
次要结局
- Change in heart rate variability (HRV)(Epilepsy Monitoring Units Stay (up to Day 7))
- Change in blood pressure variability (BPV)(Epilepsy Monitoring Units Stay (up to Day 7))
