Migraine DisordersNCT07170176
Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
A study testing Percutaneous Patent Foramen Ovale Closure in people with Migraine Disorders and Patent Foramen Ovale, run by First Affiliated Hospital Xi'an Jiaotong University at 2 sites in China.
Trial 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 that PFO may allow microemboli or vasoactive substances from venous blood to bypass pulmonary metabolism and enter the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine Disorders, Patent Foramen Ovale, Right-to-Left Shunt, Cardiac
- What is being tested?
- Percutaneous Patent Foramen Ovale Closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 14 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Guoliang Li contact
China2 sites, 2 recruiting
- Recruiting
Luoyang Central Hospital
Luoyang, Henan, 471009
Yunfei Gu, 189 3792 2758, liguoliang_med@163.com
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
Tong Liu, 139 0218 3163, liutong@tmu.edu.cn
About this study
Official title: The Impact of Percutaneous Patent Foramen Ovale Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
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.
- Being tested
- Percutaneous Patent Foramen Ovale Closure, No Intervention
- Keywords
- Patent Foramen Ovale, Migraine, Glymphatic System, PFO Closure
- Medical subject headings
- Migraine Disorders, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Patent Foramen Ovale ClosureDevice
Also called PFO Closure
Percutaneous transcatheter closure of patent foramen ovale (PFO) is a minimally invasive procedure. Under local anesthesia, a closure device is delivered via a catheter through the femoral vein to the heart to seal the PFO tunnel. The procedure is performed under fluoroscopic and echocardiographic guidance. This intervention aims to eliminate right-to-left shunt, which is hypothesized to improve migraine symptoms and glymphatic function.
No InterventionOther
This arm does not receive the PFO closure procedure. Patients in this control group are observed under their standard care regimen without any study-specific intervention.
| Study group | Role | What they receive |
|---|---|---|
| PFO with Migraine (Closure) | Experimental | 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. Receives: Device: Percutaneous Patent Foramen Ovale Closure |
| PFO without Migraine (Observation) | Other | 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly Migraine Days (MMD)
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.
Measured: For the intervention arm, this is 6 months post-procedure. For the control arm, this is 6 months post-enrollment.
Secondary outcomes (2)
Migraine Pain Intensity (VAS Score)
The change in pain intensity of migraine attacks as measured by the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable). A negative change indicates improvement.
Measured: 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
The Diffusion Tensor Imaging-Alignment along the Perivascular Space (DTI-ALPS) index is a non-invasive MRI biomarker used to assess glymphatic system function. It is calculated by obtaining diffusion tensor imaging (DTI) sequences on a 3.0T MRI scanner and measuring the diffusion coefficients along the x, y, and z axes in specific regions of interest (ROIs) near the lateral ventricles. The change in the DTI-ALPS index from baseline to the 6-month timepoint will be calculated. A positive change suggests improved glymphatic activity.
Measured: For the intervention arm, this is 6 months post-procedure. For the control arm, this is 6 months post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start14 Jan 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170176
- Sponsor's protocol ID
- XJTUIAF2025LSYY-609
- Status last verified
- Jan 2026
- First submitted
- 7 Sep 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Percutaneous Patent Foramen Ovale Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
- ClinicalTrials.gov ID
- NCT07170176
- Acronym / sponsor ID
- XJTUIAF2025LSYY-609
- Keywords
- Patent Foramen Ovale, Migraine, Glymphatic System, PFO Closure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFO with Migraine (Closure) | Experimental | Device: Percutaneous Patent Foramen Ovale ClosurePatients 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. |
| PFO without Migraine (Observation) | Other | Other: No InterventionPatients 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Patent Foramen Ovale ClosureAlso: PFO ClosurePercutaneous transcatheter closure of patent foramen ovale (PFO) is a minimally invasive procedure. Under local anesthesia, a closure device is delivered via a catheter through the femoral vein to the heart to seal the PFO tunnel. The procedure is performed under fluoroscopic and echocardiographic guidance. This intervention aims to eliminate right-to-left shunt, which is hypothesized to improve migraine symptoms and glymphatic function. | Device | PFO with Migraine (Closure) |
| No InterventionThis arm does not receive the PFO closure procedure. Patients in this control group are observed under their standard care regimen without any study-specific intervention. | Other | PFO without Migraine (Observation) |
Primary outcome
Monthly Migraine Days (MMD)
Time frame: 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.
2 secondary outcomes
Migraine Pain Intensity (VAS Score)
Time frame: 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
Time frame: For the intervention arm, this is 6 months post-procedure. For the control arm, this is 6 months post-enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guoliang Li contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Patent Foramen Ovale Closure in people with Migraine Disorders and Patent Foramen Ovale, run by First Affiliated Hospital Xi'an Jiaotong University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Yan (0086-029-85323865, yangyan3@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly Migraine Days (MMD) (time frame: For the intervention arm, this is 6 months post-procedure. For the control arm, this is 6 months post-enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.