Refractory Epilepsy
Conditions
Interventions
Treatment group:Stimulus On (True Stimulus)
Control group:Stimulus Off (False Stimulus)
Sponsors
Huashan Hospital Affiliated to Fudan University; Xuanwu Hospital of Capital Medical University
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 14 -70 years, gender is not limited; 2. Diagnosed with refractory focal epilepsy, after at least 2 anti-epileptic drugs standard treatment for more than 2 years failed to be effectively controlled, and no willingness to accept surgical resection; 3. In the past 3 months, the antiepileptic drug treatment plan has not changed (except for acute and intermittent use of benzodiazepines); 4. In the 3 months before surgery, the average number of seizures per month is >=3, and the number of seizures in any 1 month during these 3 months is not less than 2. Seizure types include: motor seizures of focal origin; focal seizures with perceptual impairment; focal progression to bilateral tonic-clonic seizures; 5. Has received multidisciplinary systematic preoperative evaluation, with no more than 2 epilepsy foci; 6. Able to fill in epilepsy diary independently or with the assistance of family members; 7. Good compliance, able to cooperate with the completion of the entire clinical trial; 8. The patient or his family can fully understand the therapy, follow up as required, and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Combined with progressive neurological disease; 2. Combined with surgical contraindications identified by surgeons and anesthesiologists; 3. Diagnosed with epileptic pseudo seizure; 4. Diagnosed with generalized seizures; 5. During lactation and pregnancy; 6. Participating in other clinical trials; 7. A vagus nerve stimulator (VNS) has been implanted, or the subject is unwilling to remove the VNS (Subjects are willing to take out VNS at the same time as the Epilcure system is implanted, and suspend VNS treatment for more than 3 months before surgery, they can be included in the study); 8. Received surgical treatment for epilepsy within the past 6 months; 9. There are other electrical stimulation implants in the body; 10. Postoperative magnetic resonance examination is required; 11. Other conditions deemed inappropriate by investigators and medical staff.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure frequency reduction percentage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Epilepsy response rate;Engel Scale Description;Quality of Life in Epilepsy Inventory (QOLIE-31);Hamilton Depression Scale(HAMD);Montreal Cognitive Assessment(MoCA);The number and types of antiepileptic medication(s);Performance evaluation; | — |
Countries
China
Contacts
Public ContactFeng Fang
Hangzhou Nuowei Medical Technology Co., Ltd.
Outcome results
None listed