Epilepsy
Conditions
Interventions
Operation group:patent foramen ovale closure and antiseizure drugs
control group:antiseizure drugs
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Age between 18 and 60 years, with no gender restrictions; (2) Diagnosis of epilepsy in accordance with the International League Against Epilepsy (ILAE) criteria (2014 edition); (3) Drug-resistant epilepsy, defined as failure to achieve sustained seizure freedom despite appropriate selection and tolerability of at least two antiseizure medications (monotherapy or combination therapy) for a minimum of six months; (4) Diagnosis of patent foramen ovale (PFO) meeting the criteria established by the American Society of Echocardiography (ASE) and the Society for Cardiovascular Angiography and Interventions (SCAI) (2015 edition), with right-to-left shunting (RLS) of grade II or higher upon Valsalva maneuver, as assessed by contrast-enhanced echocardiography; (5) Stable antiseizure medication regimen for at least four weeks prior to screening, with willingness to maintain a stable regimen throughout the study period; (6) At least one documented seizure episode during a six-week screening period (with a minimum of four weeks of effective seizure diary recordings) and a retrospective self-reported history of at least 12 seizures in the year preceding screening; (7) Ability to independently or with caregiver assistance complete a seizure diary and comply with clinical data collection and required medical examinations; (8) Willingness to undergo the investigational treatment and voluntary provision of written informed consent.
Exclusion criteria
Exclusion criteria: (1)History of cluster seizures (more than 3 seizures within 24 hours, and the level of consciousness returned to normal between seizures) during the period of receiving stable antiepileptic drug regimen (excluding temporary drug reduction or discontinuation due to treatment or examination); (2) Patients diagnosed with epilepsy of a known etiology, including infectious, metabolic, immune, genetic, or structural causes; (3) History of stroke or psychogenic nonepileptic seizures (PNES); (4) History of epilepsy surgery or implantable neurostimulation therapy, or planned epilepsy surgery, neurostimulation therapy, ketogenic diet therapy, or other antiseizure interventions during the study period; (5) Presence of structural cardiac abnormalities other than patent foramen ovale (PFO), such as moderate or severe valvular regurgitation or pulmonary hypertension; (6) Presence of severe central nervous system (CNS) diseases, including acute cerebrovascular disease, intracranial tumors, intracranial infections, or progressive CNS disorders; (7)Received general anesthesia within half a year prior to screening; or are considering undergoing any other surgery involving general anesthesia; or have been vaccinated during the screening observation period; (8) Evidence of vascular puncture site infection or difficulty with puncture as assessed by transesophageal echocardiography combined with contrast-enhanced right heart echocardiography; (9) Documented contraindications to antiplatelet therapy; (10) Presence of severe psychiatric disorders, such as schizophrenia, bipolar disorder, or severe depression or anxiety; (11) History of alcohol or other substance abuse; (12) Severe dysfunction of vital organs (heart, lungs, liver, kidneys), including but not limited to: - Severe cardiovascular disease (hospitalization or cardiac surgery due to myocardial infarction within the past three months, congestive heart failure, severe unstable arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, aneurysm, etc.); - Severe pulmonary disease (moderate-to-severe pneumonia, respiratory failure, etc.); - Hepatic or renal insufficiency; - Malignant tumors; - Active severe autoimmune diseases; - Uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg) or hypotension (systolic blood pressure <100 mmHg); - Any condition deemed by the investigator to pose a risk to the participant, affect study outcomes, or impair the participant’s ability to complete the study; (13) Pregnant or breastfeeding women, or women planning to conceive during the study period; (14) Participation in another interventional clinical trial within three months prior to signing the informed consent form, current participation in another interventional trial, or plans to participate in another interventional trial during the study period; inability to comply with follow-up due to travel or relocation; (15) Any other condition that the investigator determines makes the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage decrease in seizure frequency compared to baseline period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage decrease in mean duration of seizures from baseline period;Percentage of decrease from baseline in Epilepsy Severity Scale score (NHS3);Percentage improvement from baseline in Quality of Life Rating Scale for Patients with Epilepsy (QOLIE-31);The maximum number of observation days without sustained epileptic seizures during the follow-up observation period;The proportion of subjects whose seizure frequency decreased by more than 50% compared to the baseline period;The proportion of subjects whose average duration of epileptic seizures decreased by more than 50% compared to the baseline period; | — |
Countries
China
Contacts
Public ContactLei Chen
West China Hospital, Sichuan University
Outcome results
None listed