The Impact of Percutaneous Patent Foramen Ovale Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Monthly Migraine Days (MMD)
研究概览
简要总结
Patent Foramen Ovale (PFO) is a common congenital heart defect. Recent studies have suggested a potential association between PFO and migraines, particularly migraine with aura. It is hypothesized that PFO may allow microemboli or vasoactive substances from venous blood to bypass pulmonary metabolism and enter the arterial system directly, potentially triggering migraines. Although PFO closure has been shown to reduce the frequency and severity of migraine attacks, its long-term efficacy and underlying mechanisms require further investigation.
This study aims to explore the characteristics of glymphatic system function in PFO patients and its relationship with migraine symptoms, as well as the impact of PFO closure on glymphatic function and its role in alleviating migraine symptoms. A case-control and self-controlled before-after study design is adopted. Two groups of participants are enrolled: a case group consisting of PFO patients with significant right-to-left shunt and migraine, and a control group comprising PFO patients with significant shunt but without migraine. According to clinical guidelines and after obtaining informed consent, eligible patients in the case group undergo percutaneous PFO closure.
By comparing migraine symptoms and glymphatic function indicators both before and after the procedure between the two groups, the interventional effect of PFO closure and its potential mechanism will be investigated. The primary endpoint is the improvement in migraine symptoms, while the secondary endpoints include glymphatic function metrics. The findings of this study will provide new theoretical insights and clinical guidance for the management of PFO-related migraines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 60 years.
- •Diagnosed with patent foramen ovale (PFO) with significant right-to-left shunt.
- •For the case group: Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders (ICHD-3).
- •For the control group: No history of migraine.
- •Willing and able to provide written informed consent.
- •Education level of primary school or higher.
排除标准
- •Patients with a history of PFO closure or other migraine-related surgical treatments;
- •Patients with other severe cardiac or neurological diseases, mental disorders, or psychological conditions;
- •Patients with contraindications to closure surgery or MRI scans (e.g., severe infection, coagulation dysfunction, cardiac pacemakers, aneurysm clips, metallic foreign bodies in the eye, non-removable metal dentures, etc.);
- •Patients unable to complete migraine symptom assessments or imaging examinations due to other reasons.
研究组 & 干预措施
PFO with Migraine (Closure)
Patients with patent foramen ovale (PFO) and migraine receive percutaneous PFO closure intervention. This group will be assessed for migraine symptoms and glymphatic function before and after the procedure.
干预措施: Percutaneous Patent Foramen Ovale Closure (Device)
PFO without Migraine (Observation)
Patients with patent foramen ovale (PFO) but without migraine. This group does not receive closure intervention and serves as the control group for observational comparison. They will undergo the same assessment schedule as the intervention group.
干预措施: No Intervention (Other)
结局指标
主要结局
Monthly Migraine Days (MMD)
时间窗: For the intervention arm, this is 6 months post-procedure. For the control arm, this is 6 months post-enrollment.
The number of days with migraine headache per month, as recorded by participants in a daily headache diary. The change in MMD from baseline to 6-month follow-up will be calculated. A decrease in MMD indicates improvement.
次要结局
- Migraine Pain Intensity (VAS Score)(The pain intensity of migraine attacks as measured by the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable). The change in VAS score from baseline to the 6-month timepoint will be calculated. A negative change indicates)
- DTI-ALPS Index(For the intervention arm, this is 6 months post-procedure. For the control arm, this is 6 months post-enrollment.)