A Randomised Placebo Controlled Clinical Trial of Light Therapy for Medically Intractable Epilepsy.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of seizures/month
研究概览
简要总结
This study is designed to investigate whether light therapy may be an effective treatment for some people with epilepsy. Light treatment is already an established treatment for depression. The chemical systems in the brain that are disrupted when someone becomes depressed, overlap with some of those that can be affected during some epileptic seizures. The investigators have designed this study to see whether light therapy may also lead to a decrease in seizures in people who have epilepsy.
The study will be a placebo controlled trial. This means that half of the participants will receive a therapeutic dose of light therapy from a light box, whilst the other half will only receive a placebo light treatment.
详细描述
The aim of this study is to investigate a new, non invasive treatment for epilepsy that may be useful as an adjunctive therapy for people whose seizures are poorly controlled with anti epileptic drugs. Light therapy is a well established treatment for some forms of depression. From the cellular level to epidemiological studies, there are numerous strands of evidence in the scientific literature that indicate that light therapy could be also an effective treatment for some people with epilepsy.
The proposed study is a randomised placebo controlled trial of light therapy. One hundred people with medically refractory epilepsy will be recruited. Participants will be randomised to receive either therapeutic or placebo doses of light therapy from an identical device for 30 minutes a day during the treatment phase of the study. The statistical power of this study design is >90% to detect a 25% reduction in seizure frequency during the treatment phase. Although this therapeutic approach is more likely to be palliative than curative, it represents a non invasive and relatively inexpensive add-on treatment option for a sub group of patients who may have reached the end of the road in other medical and surgical treatment options.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically intractable epilepsy
- •Min 4 complex partial seizures/ month
排除标准
- •Ability to give informed consent
- •Underlying progressive neurological condition
结局指标
主要结局
Number of seizures/month
时间窗: 3 months
次要结局
- Mood(3 months)
