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Mechanism of patent foramen ovale closure in the auxiliary treatment of drug refractory epilepsy in adults based on multi-modal MRI and electrophysiological techniques

Mechanism of patent foramen ovale closure in the auxiliary treatment of drug refractory epilepsy in adults based on multi-modal MRI and electrophysiological techniques

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300075843
Enrollment
Unknown
Registered
2023-09-18
Start date
2023-09-18
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

epilepsy

Interventions

PFO closure group:patent foramen ovale closure and antiepileptic drugs
Epilepsy control group:NA
Healthy control:None

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for epilepsy of the International Anti epileptic Alliance (ILAE) (2014 version) and the diagnostic criteria for refractory epilepsy (2010 version); (2) The frequency of epileptic seizures was = 1 time per three month; (3) Aged 18-60 years old; (4) The patient agreed to the treatment of this study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) The study participants have cognitive impairment, with an MMSE score of = 23; (2)Severe mental illness or substance abuse; (3) Pregnancy, lactation or pregnancy planning within one year;(4) Participating in other interventional clinical trials; (5)Patients judged by the investigator to be unfit for clinical trials; (6) Presence of metals in the body or other contraindications for magnetic tests.

Design outcomes

Primary

MeasureTime frame
MRI;MEG;EEG;The average monthly seizure frequency decrease in one year;Duration of seizure attack;

Secondary

MeasureTime frame
Improvement of epilepsy severity;Improvement of epilepsy severity;Degree of depression;Anxiety level;

Countries

China

Contacts

Public ContactChen Lei

West China Hospital, Sichuan University

leilei_25@126.com+86 189 8060 5819

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026