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A Study on a Treatment for Post-PFO Migraines

A Study on the Efficacy of a Combined Block of the C2 Dorsal Root Ganglion, the Posterior Medial Branch of C3, and the Third Occipital Nerve in Migraines Following PFO Closure

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128158
Enrollment
Unknown
Registered
2026-07-15
Start date
2026-07-15
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of Residual Migraines Following PFO Closure

Interventions

Intervention Group:Combined block of the C2 dorsal root ganglion, the C3 posteromedial branch, and the third occipital nerve The concentration of the anaesthetic is: 0.1% ropivacaine
injection dose: 0.5–1 ml per nerve target
Control group:No block therapy was administered following the PFO closure procedure

Sponsors

Jinshan Hosptial of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

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

MeasureTime frame
Change in the average number of migraine days per month (primary endpoint);

Secondary

MeasureTime 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

Public ContactWu Chengxiao

Jinshan Hosptial of Fudan University

262230295@qq.com+86 21 34189990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026