Antibodies Causing Epilepsy Syndromes: The ACES Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 582
- 试验地点
- 8
- 主要终点
- frequency of patients with known and novel antibodies
研究概览
简要总结
The Antibodies Causing Epilepsy Syndromes (ACES) Study is a observational cohort study focusing on detection of auto-immune epilepsy in patients with epilepsy of unknown origin.
详细描述
Recently new treatable causes of epilepsy have been identified. These disorders are caused by a disruption of the balance in the brain caused by inflammation. This inflammatory reaction is caused by an autologous reaction of the immune system to specific brain proteins. The body produces antibodies to specific parts of the brain. These disorders can lead to epilepsy, memory dysfunction and psychiatric problems. Recognition is necessary for good treatment. Mostly anti-epileptic drugs are insufficient. These diseases can be treated with immune-modulating therapy. The ACES Study will focus on determining the frequencies of known antibodies and finding new, currently unknown, antibodies, causing epilepsy. Therefore patients will be investigated with epilepsy of unknown origin. To find new antibodies sera of patients with epilepsy will be added to brain sections of rats and to cultivated neuronal cells to look for a reaction. If new antibodies will be detected clinical features will be mapped of the patients. Also effects of antibodies on brain cells will be determined. Discovery of new antibodies can provide new treatment options for these patients. Also it will enable to discover more about the pathologic mechanisms of epilepsy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 of 18 and older.
- •Status epilepticus or new onset seizures with signs of limbic encephalitis (clinical picture, MRI (FLAIR abnormalities), EEG abnormalities or CSF findings (CSF pleocytosis, increased IgG index, oligoclonal bands), or:
- •Patients with acquired chronic focal epilepsy with an unknown cause.
排除标准
- •Epilepsy with known cause
结局指标
主要结局
frequency of patients with known and novel antibodies
时间窗: 3 year
detection of specific known and novel, currently unknown, auto-antibodies by immunohistochemistry, live hippocampal neuron cultures and cell-based assay
次要结局
- modified Rankin scale(1 year)
- Seizure frequency(1 year)
- Treatment response(3 months)
研究者
M.J. Titulaer
MD. PhD.
Erasmus Medical Center