SONATA: Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Music Intervention and its effects on epileptic activity in human brain
研究概览
简要总结
This is a prospective, placebo-controlled, double-blinded randomized study of self-administered auditory intervention in a naturalistic home environment.
详细描述
This study aims to replicate and extend findings from prior electrophysiological studies that demonstrated a reduction in epileptiform discharges and seizures in patients living with drug-resistant (medications are not effective) epilepsy after listening to specific music.
It is believed to be the first study to examine the effect of daily, self-administered musical stimuli in reduction of epileptiform event detections over days to weeks. The study will enroll a cohort of patients already implanted with NeuroPace Responsive Neurostimulator (RNS) device to treat their epilepsy. This device uses continuous, outpatient electrocorticographic recording data to provide immediate (or 'responsive') closed loop neurostimulation.
Primary hypothesis is that patients with drug resistant epilepsy, implanted with RNS, will have fewer epileptic activity episodes (RNS 'long episodes') during the weeks of experimental music intervention. The study team expect to see improvement with daily listening to specific music intervention (experimental, Music A), but not with active comparators (Music B or C). The effect, if any, of music intervention is expected to last at least one week after the intervention period (block) (for each music piece) ends.
Secondary hypothesis is that the music listening every day will be associated with improved self-report of mood, quality of life, and self-reported measures of cognition. The study team suspects that this effect will not be limited to just one specific musical piece.
This study will also look to determine the feasibility of an at-home, self-administered auditory intervention in drug resistant epilepsy.
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
- Double (Participant, Investigator)
盲法说明
Participants will not be informed of their group assignment. The study team will have no knowledge of randomization sequence until all participants complete the study.
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
- •Adults with medication-refractory focal epilepsy who have undergone RNS implantation at least six months prior and are in the judgement of the treating physician on a stable RNS regimen in terms of stimulation
- •Willing to attend all study visits and complete all required study procedures
- •Access to private or public wireless data service at regular intervals
- •Access to personal mobile device
排除标准
- •Documentation of a musicogenic, or auditory-triggered focal seizure semiology
- •Participant is unable to reasonably participate in study tasks as determined by the investigator
- •Inability to obtain informed consent from the patient or legally authorized representative
研究组 & 干预措施
Music Piece C
Participants will select a preferred excerpt from several popular musical genres. This piece is modified to have some similarities to the experimental musical excerpt.
干预措施: Active Comparator Intervention (Music C) (Other)
Music Piece A
Participants will be asked to listen to a musical excerpt previously shown to have a positive effect on epileptic activity in human brain.
干预措施: Experimental Intervention (Music A) (Other)
Music Piece B
Participants will be asked to listen to a musical except very similar to the experimental stimuli that has not been shown to have a positive effect on epileptic activity.
干预措施: Active Comparator Intervention (Music B) (Other)
结局指标
主要结局
Music Intervention and its effects on epileptic activity in human brain
时间窗: Baseline, Week 3-4, Week 9-10, and Weeks 13-14, (Approximately 4 1/2 Months)
This measure aims to determine if specific music intervention has positive effect on epileptic activity in participants with responsive neurostimulation device (RNS) implanted for drug-resistant epilepsy (DRE). The effect will be measured as a change in the number of "long episodes" or epileptic activity in a participants' brain as detected and recorded by the RNS device before and after study music interventions.
次要结局
- Reduction in patient-reported seizures(Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment))
- Assessment of pre- and post-intervention mood (DASS-21)(Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment))
- Assessment of pre- and post-intervention cognition scores (BRIEF-A)(Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment))
- Determining duration of therapeutic effect of music intervention(Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment))
- Assessment of pre- and post-intervention quality of life (QOLIE-31)(Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment))
- Assessment of music preferences pre- and post-intervention(Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment))
- Assess feasibility of real-world, at home auditory stimulus interventions for patients with drug resistant epilepsy(Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment))
研究者
Brian Fidali, MD
Principal Investigator
Dartmouth-Hitchcock Medical Center