Status:

RECRUITING

Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine

Lead Sponsor:

First Affiliated Hospital Xi'an Jiaotong University

Conditions:

Migraine Disorders

Patent Foramen Ovale

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief Summary

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 tha...

Eligibility Criteria

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.

Key Trial Info

Start Date :

January 14 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2027

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT07170176

Start Date

January 14 2026

End Date

December 31 2027

Last Update

January 16 2026

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Luoyang Central Hospital

Luoyang, Henan, China, 471009

2

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China, 300211

Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine | DecenTrialz