Treatment of Residual Migraines Following PFO Closure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ages 18–55; 2.Patients who meet the diagnostic criteria for migraine (including migraine with aura) as defined by the International Classification of Headache Disorders, 3rd Edition (ICHD-3), whose headaches have significantly impacted their daily life and work, or who have ischemic lesions detected on cranial MRI and have undergone percutaneous foramen ovale occlusion; 3.Patients without mental illness; 4.Patients without aphasia or hearing loss;
Exclusion criteria
Exclusion criteria: 1. Patients who refuse to sign an informed consent form; 2.Patients with mental illnesses; 3.Patients who are unable to communicate effectively; 4.Individuals who are allergic to the local anesthetics used in this trial; 5.Patients with skin ulcers or infections at the puncture site; 6.Patients with coagulation disorders;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the average number of migraine days per month (primary endpoint); | — |
Secondary
| Measure | Time frame |
|---|---|
| Medication Usage: Average Monthly Usage of Analgesics During the Acute Phase (Drug Type, Dosage);Duration of each headache (minutes);A >=20% decrease in the PSQI score;Changes in HRV (Dynamic trends in the LF/HF ratio, reflecting autonomic balance);VAS Score;Improvement in Depression (=30% reduction in BDI-II score);Permeability Index (PI); | — |
Countries
China
Contacts
Jinshan Hosptial of Fudan University