Patent foramen ovale closure and refractory epilepsy
Conditions
Interventions
Operation group:patent foramen ovale closure and antiepileptic drugs
control group:sham-operation group+antiepileptic drugs
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) It conforms to the diagnostic criteria for epilepsy of the International Anti epileptic Alliance (ILAE) (2014 version); (2) Meet the diagnostic criteria for intractable epilepsy (2010 version); (3) Unknown etiology according to the International Anti Epilepsy Alliance (ILAE) classification of epilepsy etiology (2017 version); (4) The right to left shunt of the study participants is at level II or above; (5) The maximum number of microbubbles>=10(i.e., the left ventricular lumen appears on a stationary single frame image); (6) Aged 18-60 years old and able to complete epilepsy diary independently or with the help of family members; (7) All antiepileptic drug treatment must be stable for one month before screening, and the patient is willing to maintain a stable antiepileptic drug program throughout the study; (8) Before screening, the frequency of epileptic seizures was = 1 time per month; (9) The patient agreed to the treatment of this study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) The study participants had a history of false epileptic seizures; (2) During screening, study participants found other cardiac structural abnormalities (including moderate or above valve regurgitation and pulmonary hypertension) other than patent foramen ovale; (3) The study participants have severe mental illness or anxiety and depression, with an anxiety scale score of>21 and a depression scale score of>20; (4) The study participants have cognitive impairment, with an MMSE score of = 23 or a MoCA score of<26; (5) Infection or difficulty in blood vessel puncture; (6) There were contraindications of antiplatelet therapy for open traumatic fracture, gastrointestinal ulcer, active bleeding, visceral bleeding, etc. within three months before screening; (7) Suffering from serious digestive, circulatory, respiratory, liver, urinary system, skeletal muscle system, blood immune system diseases or genetic metabolic diseases, or the researcher believes that the patient's disease or obstacle may cause the patient to be in danger due to participating in the study, or may affect the study results, or may affect the patient's ability to participate in the study; (8) Patients who have undergone head surgery and neuromodulation; (9) The patient is considering epilepsy related surgery or any surgery involving general anesthesia, or the patient has received general anesthesia within four weeks before screening; (10) Patients shall be vaccinated within the screening period or four weeks before the screening period; (11) Female patients who are pregnant (positive pregnancy test), breastfeeding or planning to become pregnant during the study and within three months after the study; (12) Participants in other intervention clinical trials during the trial; (13) The patient was unable to follow up if he planned to travel or live in other places during the study period; (14) The investigator judged that it was not suitable to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average monthly seizure frequency decrease in one year; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of seizure attack;Improvement of epilepsy severity;Quality of life score;Cognitive function level;Degree of depression;Anxiety level;Sleep quality;Headache severity;Hematological indicators;Blood biochemical indicators;Incidence rate of adverse reactions;Incidence rate of serious adverse events; | — |
Countries
China
Contacts
Public ContactLei Chen
West China Hospital, Sichuan University
Outcome results
None listed