Prevention of Photoparoxysmal Abnormalities Through Patterned Auditory Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Decreased duration (>25%) of photoparoxysmal response(s) during exposure to K-448
研究概览
简要总结
The purpose of this clinical trial is to examine the effect of non-invasive cortical activation by specific patterned auditory stimulation (Mozart K448- Piano Sonata for Two Hands in D Major), in altering or eliminating photoparoxysmal abnormalities. Recent work has indicated that such evoked activity (i.e. by specific music) can result in significant reductions, or even complete termination of epileptiform activity and/or seizures across a broad range of individuals with epilepsy. A hypothesis is generated that specific music activation would beneficially effect photoparoxysmal based epileptiform abnormalities.
详细描述
Non-pharmacologic, non-surgical treatments for seizures and epilepsy are of increasing importance, given the potential side effects as well as lack of complete seizure control with such treatments. Based on previous studies demonstrating an anti-convulsant and anti-epileptiform effect achieved in subjects by music exposure, it is proposed that specific musical stimuli may causally result in widely distributed cortical activation in such a fashion as to effectively prevent or terminate epileptiform abnormalities in subjects with photosensitive epilepsy. We will investigate the effect of specific musical stimulation (Mozart K448) to reduce or prevent photoparoxysmal abnormalities in subjects.
Primary outcome will be evaluated in 3 groups, assessing alteration/cessation of photic-induced abnormalities during:
- Treatment: music exposure to Mozart K448, vs.
- Placebo: music exposure to Beethoven's Für Elise for piano, vs.
- Control: no music exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5-17 years, inclusive
- •Female or male with photoparoxysmal epilepsy clinical history, and at least one seizure, as defined by the International League Against Epilepsy (International Classification of Epilepsies and Epileptic Syndromes; Commission on Classification and Terminology of the International League Against Epilepsy 1989)
- •Abnormal EEG consistent with features of photoparoxysmal epilepsy: occipital based epileptiform abnormalities with otherwise normal background interictal EEG;
- •On < or equal to 2 anti-seizure medications [range 0-2 AEDs]
排除标准
- •History of a generalized convulsion provoked by photic stimulation;
- •Inability to complete and/or comply with study protocol
结局指标
主要结局
Decreased duration (>25%) of photoparoxysmal response(s) during exposure to K-448
时间窗: Each participant will have a single one hour EEG for data aquistition.
Each participant will have a single one hour EEG for data aquistition. The recorded EEG data will be analyzed to determine significant causal reductions or prevention of photoparoxysmal responses resulting from the auditory stimulation, along with determining all induced patterns of cortical activation.
次要结局
未报告次要终点
研究者
Robert P. Turner
Assoc Prof Neurosciences
Medical University of South Carolina