Predicting and Monitoring Outcomes in Autoimmune Encephalitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Seizure frequency
研究概览
简要总结
Epilepsy is a disorder of the brain in which people have repeated seizures.
Autoimmune encephalitis (AE) is a rare cause of epilepsy. It is an inflammatory disease of the brain. This means that the body's own immune system attacks healthy brain tissue, just like it would if it were infected by a virus or a bacteria, by producing an army of proteins called 'antibodies' which go on to 'attack' healthy tissues.
Seizures in AE typically do not respond well to classic 'anti-seizure medications'. Instead, medications which suppress the immune system are used. These can have significant side-effects and some patients will still continue to have seizures or experience a recurrence of AE-related epilepsy despite treatment. It is difficult to accurately predict who will experience these outcomes.
This study aims to find ways of predicting and monitoring which people with AE are at greatest risk of these outcomes, so we can better direct them towards appropriate treatments. We will collect clinical information and samples of blood and cerebrospinal fluid (CSF, fluid surrounding the brain and spinal cord) from people with AE and 'control' participants with other neurological illnesses. Samples will be analysed for markers which may help predict or correlate with outcomes in AE and better understand this condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AE participants over the age of 18 will be recruited if they meet the criteria for clinically probable or clinically definite Autoimmune Encephalitis as per Graus and colleagues
- •Neurological Control participants undergoing lumbar puncture as part of clinical care for other, non-encephalitis disorders (e.g. for investigation of headache where meningitis or encephalitis is not detected, for investigation and treatment of idiopathic intracranial hypertension) in Beaumont hospital will be recruited.
排除标准
- •AE participants
- •Under 18 years of age
- •Participants without AE or those with a definitive alternate diagnosis for presentation.
- •Other neurological control participants will be excluded if they have a current or historic diagnosis of AE.
结局指标
主要结局
Seizure frequency
时间窗: 1-3 years
\>50% improvement in seizure frequency over time
Functional status
时间窗: 1-3 years
Modified Rankin score
次要结局
- Sleep Quality(1-3 years)
- Quality of life(1-3 years)
- Cognitive ability(1-3 years)
- Clinical status(1-3 years)
- Mood/affect(1-3 years)
- Pain(1-3 years)
- Fatigue(1-3 years)
- Impulsivity(1-3 years)
- Neuropsychiatric symptoms(1-3 years)