Intractable epilepsy
Conditions
Interventions
experimental group:The handheld endomicroscope system assisted epileptic foci resection
control group:Traditional method for epileptic foci resection
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
6 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 6 years old to 65 years old; 2. Participants in the study who were clinically diagnosed with refractory epilepsy (the International League Against Epilepsy defined refractory epilepsy in 2010 as: after the rational selection and correct use of at least two well-tolerated antiepileptic drugs (ASMs) based on the type of epileptic seizure, the duration without seizure of the study participants did not reach three times or one year of the longest seizure interval before treatment); 3. The epileptic focus to be resected is located in a non-functional area (including motor and language areas) , confirmed by imaging and/or SEEG; 4. Be willing to receive Epileptic focus resection, be willing to cooperate and complete the research follow-up and related examinations; 5. Voluntarily participate in this trial and sign the informed consent form in person (for minor research participants, the form should be signed by the guardian on their behalf);
Exclusion criteria
Exclusion criteria: 1. Exclude medial temporal lobe epilepsy and tumor epilepsy; 2. Have severe cardiovascular or circulatory system diseases and cannot tolerate surgery; 3. Have participated in other clinical trials of investigational drugs or devices within the past month; 4. Unable to understand the test requirements or unable to complete the research follow-up plan. 5. Pregnant and lactating women; 6. Research participants with severe mental illness, cognitive or emotional disorders who are unable to complete the follow-up; 7. The researcher believes there are other circumstances that make enrollment unsuitable;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative epilepsy recurrence rate;Postoperative control of epileptic seizures; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative neurological function evaluation;The accuracy of the handheld endomicroscope system in identifying epileptic foci;Perioperative safety; | — |
Countries
China
Contacts
Public ContactLiang Chen
Huashan Hospital, Fudan University
Outcome results
None listed