Closing a PFO to improve glymphatic function and migraine symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial enrolls adults with significant right-to-left shunt due to PFO and compares them with control participants without migraine using a case-control and self-controlled before-and-after design. Participants in the case group undergo percutaneous PFO closure and are followed with imaging of glymphatic system metrics plus standardized migraine symptom assessments before and after the procedure. Controls undergo the same imaging and clinical assessments without closure to characterize baseline differences. The design aims to link changes in glymphatic measures to changes in migraine frequency and severity over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged 18 to 60 years.
2. Diagnosed with patent foramen ovale (PFO) with significant right-to-left shunt.
3. For the case group: Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders (ICHD-3).
4. For the control group: No history of migraine.
5. Willing and able to provide written informed consent.
6. Education level of primary school or higher.

Exclusion Criteria:

1. Patients with a history of PFO closure or other migraine-related surgical treatments;
2. Patients with other severe cardiac or neurological diseases, mental disorders, or psychological conditions;
3. 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.);
4. Patients unable to complete migraine symptom assessments or imaging examinations due to other reasons.

Where it's running

• Luoyang Central Hospital
  Luoyang, Henan, China Recruiting
• The Second Hospital of Tianjin Medical University
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Yang Yan
• Email: yangyan3@xjtu.edu.cn
• Phone: 0086-029-85323865

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Long-term outcomes after PFO closure at Severance Hospital

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• PFO-Directed Therapy for Migraines: Closing the Hole or Using a Blood Thinner

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• Greater Occipital Nerve Block for Migraine with Medication Overuse Headache

  This study will test whether a nerve block using lidocaine and methylprednisolone can help people with migraine who overuse medications to reduce withdrawal headaches during detoxification.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.