Nonrandomized Pilot Trial of the Andrews/Reiter Behavioral Treatment for Epilepsy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Seizure frequency
研究概览
简要总结
The purpose of this research study is to see if a behavioral program which includes a relaxation technique and lifestyle changes can improve seizure control and well-being in epilepsy patients.
详细描述
The behavioral treatment approach studied aims to help epilepsy patients discover which circumstances and behaviors trigger their seizures. The most common seizure precipitants are irregularities of sleep, sensory triggers such as flashing lights and emotional stress. Patients will learn how to avoid seizure precipitants and how to stop seizures in their first beginnings. Study participants will continue their prior medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16-50 years.
- •Reliable diagnosis of partial epilepsy, including simple or complex partial or secondarily generalized tonic-clonic seizures.
- •Average seizure frequency of at least one partial seizure per month for at least one year.
- •Willing not to begin another new treatment other than anticonvulsants (acupuncture, botanicals or other mind-body interventions, ketogenic diet, vagus nerve stimulator, or epilepsy surgery) while enrolled in the study.
排除标准
- •Unreliable history of seizure semiology.
- •Average seizure frequency less than one seizure per month.
- •Patients in whom it is anticipated that current standard of care would mandate a change in their conventional epilepsy treatment during the time period of the study will be excluded.
- •Patients taking more than 2 anticonvulsant medications will be excluded.
- •Patients with serious other medical problems, such as brain tumors, cancer, stroke, significant heart disease or psychiatric disorders will be excluded.
- •Patients with a high likelihood of psychogenic or nonepileptic seizures will be excluded.
- •Patients with progressive epilepsy syndromes, neurodegenerative disorders or significant mental retardation will be excluded.
研究组 & 干预措施
2
Receives only EEG and questionnaire testing, no behavioral intervention or meditative relaxation
1
Andrews/Reiter behavioral treatment for epilepsy and EEG and questionnaire testing
干预措施: Andrews/Reiter behavioral treatment for epilepsy (Behavioral)
结局指标
主要结局
Seizure frequency
时间窗: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
次要结局
- Epileptiform EEG changes(At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.)
- Heartrate variability(At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.)
- Questionnaires on stress, emotional well-being, self-efficacy, sleepiness and quality of life(At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.)
- Salivary cortisol(At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.)