Refractory Epilepsy
Conditions
Interventions
Treatment group:Stimulation on
Control group:Stimulation off
Sponsors
Xuanwu Hospital, Capital Medical University; Beijing Children's Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 70 Years
Inclusion criteria
Inclusion criteria: If you answer "no" to any of the following criteria, you will not be allowed to participate in this clinical trial. (1) Subject is between the ages of 18 and 70 years, gender is not limited. (2) Diagnosed with refractory focal epilepsy, and no suitable for or no willingness to accept surgical resection. (3) Subject has remained on the same antiepileptic medication(s) over the 3 most recent consecutive months (other than acute, 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. (5) Has received multidisciplinary systematic preoperative evaluation, with no more than 2 epilepsy foci. (6) Subject can be reasonably expected to maintain a seizure diary alone or with the assistance of a competent individual. (7) The patient or his family can fully understand the therapy, have good compliance, voluntarily sign the informed consent, follow up as required, and can cooperate with the whole clinical trial. Drug resistant epilepsy is defined as failure of adequate trials of two tolerated, appropriately chosen and used antiepileptic drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom. Participants who have temporarily discontinued antiseizure medication for a short period of time for medical diagnostic purposes within the past 3 months may still be eligible for enrollment.
Exclusion criteria
Exclusion criteria: If you answer "yes" to any of the following criteria, you will not be allowed to participate in this clinical trial. (1) Subject has been diagnosed with non-epileptic seizures. (2) Subject has been diagnosed with generalized seizures. (3) Combined with severe psychosis or progressive neurological diseases. (4) Coagulation dysfunction and cannot stop anticoagulant drugs. (5) Subject has had therapeutic surgery to treat epilepsy in the preceding 6 months. (6) The researchers determined that the cranial condition was not suitable for implantation of this product. (7) A vagus nerve stimulator (VNS) has been implanted, or the subject is unwilling to remove the VNS/ have the VNS explanted. (Subjects are willing to take out VNS at the same time as the Implantable Closed-Loop (Brain)Neural Acquisitor & Stimulator System is implanted, and suspend VNS treatment for more than 3 months before surgery, they can be included in the study). (8) There are other electrical stimulation implants in the body. (9) During lactation and pregnancy. (10) Participants who have participated in other clinical trials within three months before surgery. (11) Other conditions deemed inappropriate by investigators and medical staff.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure frequency reduction percentage;Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| responder rate;The relative baseline changes of the Hamilton Depression Scale (HAMD) and Hamilton Anxiety Scale(HAMA) in postoperative epilepsy patients. ;The success rate of immediate implants;The relative baseline changes of the Montreal Cognitive Assessment scale in postoperative epilepsy patients.;Engel Scale Description;Quality of Life in Epilepsy Inventory, QOLIE-31/ Quality of Life in Childhood Epilepsy Questionnaire, QOLCE;Performance evaluation; | — |
Countries
China
Contacts
Public ContactGuoguang Zhao/Shuli Liang
Xuanwu Hospital, Capital Medical University Beijing Children's Hospital, Capital Medical University
Outcome results
None listed