Pre-emptive Treatment in Epilepsy Using Electronic Diaries: Towards a New Frontier in Epilepsy Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 6
- 主要终点
- Change in seizure frequency
研究概览
简要总结
The study will examine whether a stress reduction intervention reduces the number of seizures in people with drug resistant epilepsy.
详细描述
The study will examine whether a stress reduction intervention reduces the number of seizures in people with drug resistant epilepsy. In the proposed randomized controlled, double blind trial, the investigators will enroll subjects with frequent seizures, especially those who identify stress as a seizure precipitant. There is an observational phase (8-12 weeks) and a treatment phase (12 weeks). During the observational phase, subjects will be monitored multiple times daily via smart phone devices, in order to identify high risk days for seizures. In the treatment phase, subjects will be randomly assigned to one of two groups receiving different focused attention practices. These behavioral interventions will be administered daily with extra interventions applied on days of higher risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age 18 years and above
- •English speaking
- •Partial epilepsy consistent with ILAE criteria supported by either EEG or MRI data
- •Experiencing at least 2 seizures/month
- •Reported awareness of all seizures, including seizures in a cluster
- •One of the following:
- •Patient-reported ability to self-predict seizures
- •Patient-reported awareness of trigger factors, including stress
- •Patient-reported awareness of premonitory features
- •Able to maintain accurate e-diary independently
- •Minimum 6th grade reading level as screened by WRAT administration
- •Must be on a stable dose of anti-epileptic drugs for at least 30 days prior to study entry
- •May be on stable dose of SSRI, SNRI, or atypical antipsychotic for at least 6 months
- •May be on a stable dose of benzodiazepines (if so, dose stable for at least 30 days prior to study entry)
- •For inclusion in clinical trial phase, patient must be/have:
- •A minimum of 4 seizures documented in the 8-week baseline phase (or 6 seizures in the 12-week extended baseline phase)
- •At least 1 seizure per 4-week period in two of the three 4-week periods in the extended baseline phase
- •Diaries satisfactorily completed during baseline phase
- •Complied with study requirements during the baseline phase
排除标准
- •Non-motor simple partial seizures only
- •Concurrent VNS use
- •History of suicide attempt within the past 2 years
- •Current suicidality
- •Not competent to sign consent
- •Status epilepticus within the previous 6 months
- •Began regularly using behavioral techniques for stress reduction within past 3 months
- •Did not benefit from an adequate trial of a valid stress reduction technique
- •Progressive neurologic condition that the investigator believes would affect seizure frequency
- •Any history of substance abuse within the previous 2 years
- •History of poor medication compliance as judged by the investigator
- •Psychiatric illness that requires change in medication dose
- •Any medical or psychiatric condition that would impair reliable participation in the trial
- •Intermittent use of benzodiazepines (if used for sleep, will be determined case by case)
研究组 & 干预措施
Progressive muscle relaxation
Subjects practice a progressive muscle relaxation exercise for 15 minutes every AM and 5 minutes every PM
干预措施: Progressive muscle relaxation (Behavioral)
Sham exercise
Subjects practice a sham exercise consisting of focused attention activities
干预措施: Sham exercise (Behavioral)
结局指标
主要结局
Change in seizure frequency
时间窗: End of baseline and end of 12 week clinical trial
次要结局
未报告次要终点
研究者
Sheryl Haut
Prof. Dept of Medicine (Critical Care)
Montefiore Medical Center