Investigation of Autoimmunity in migraine patients: A perspective case-controlled study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- This study will compare the levels of autoantibodies in migraine patients with those of healthy volunteers in order to determine whether immunological malfunction may be the cause of migraine attacks.
研究概览
简要总结
Migraine is a neurological disorder characterized by repeated, moderate to severe headaches. Usually, one side of the brain is affected by throbbing episodes that last between a few hours to three days. Though the exact pathophysiology of migraine is still unclear, several initial treatments such as monoclonal antibodies, NSAIDs, Triptans etc., are currently available to treat migraine. Unfortunately, none of these treatments provide sufficiently tangible therapeutic advantages for migraine patients. On the other hand, our recent analysis found that CD4+CD25+ regulatory T cells (Treg) are reduced in migraine patients as compared with healthy volunteers. Tregs are the subset of CD4+ T cells that play a role in regulating or suppressing other cells in the immune system.
In support of this, during the impact of COVID-19, people with pre-existing migraine or those who had never experienced a headache in their lifetime were affected. Headache is a common symptom of SARS-CoV2 (active COVID-19), and people develop a persistent headache after having COVID-19, which is said to be a post-COVID headache, even though it continues after having a negative result of the infection. People who have been exposed to COVID-19 may experience post-COVID headaches, but this effect is worsening in migraine patients. Accordingly, covid vaccination also aggravates the migraine attacks in patients. After the vaccination, pre-existing migraine patients develop a more severe, long-lasting, and hard-wearing migraine attacks compared to normal patients. Overall, it suggests that an immunological imbalance in the body plays a major role in migraine’s progression.
Therefore, in this observational study, an autoantibody test will be conducted on the migraine patient’s blood samples which may confirm that migraine could be an autoimmune disorder.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- Female
入选标准
- •Migraine with aura and without aura patients
- •Patients between 18 to 60 years old
- •Patients affected by COVID-19
- •Patients with other autoimmune disorder.
排除标准
- •Migraine patients with other comorbid diseases
- •Patients who had not taken any medications for migraine
- •Pregnant and lactating women.
结局指标
主要结局
This study will compare the levels of autoantibodies in migraine patients with those of healthy volunteers in order to determine whether immunological malfunction may be the cause of migraine attacks.
时间窗: Investigation of 6 months
次要结局
- This study will detect the autoantibody levels in migraine patients and will help in better understanding of migraine as an autoimmune disorder(Investigation of 1 year)
