Drug-refractory generalized epilepsy
Conditions
Interventions
Treatment group:Stimulation on after 4weeks(D28±7) of implantation
Sponsors
Fudan University HuaShan Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 20 Years
Inclusion criteria
Inclusion criteria: (1) Patients with drug-refractory generalized epilepsy; (2) Age = 8 years old and = 20 years old, gender is not limited; (3) seizures 3 or more times per month; (4) the subject and his or her family have a reasonable expectation that the subject will be able to keep a seizure diary alone or with the help of family members; (5) Voluntarily participate in this trial and sign a written informed consent form; (6) Preoperative evaluation through surgical treatment of epilepsy; (7) Not participating in other clinical trials within three months.
Exclusion criteria
Exclusion criteria: (1) Have received DBS implantation in the past; (2) Active implants such as pacemakers, defibrillators, cochlear implants, drug infusion pumps, other neurostimulators, etc., or passive implants that affect the stimulator system; If the patient already has an implantable vagus nerve stimulator (VNS) in his body, he or she can participate in this trial after turning off the VNS; (3) Patients with contraindications to neurosurgery and severe cardiovascular and cerebrovascular diseases; (4) Clinically significant or unstable medical condition (including alcohol and/or drug abuse) or progressive central nervous system disease; (5) Combined with serious abnormalities in liver and kidney function and other systemic diseases that seriously affect health; (6) Women who are pregnant or have the intention to become pregnant in the past year, or lactating women; (7) Subjects judged by the investigator to have poor compliance with the subject, or subjects who are not suitable to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| responders‘ rate (proportion of patients with a =50% duction of seizures from baseline in the epilepsy diary at the last visit);The median relative decrease of seizures recorded in the epilepsy diary at the last visit;The proportion of patients with a =50% duction of seizures from baseline in 24-hour HD-EEG at the last visit.;The median relative decrease of seizures in 24-hour HD-EEG at the last visit.;Wechsler Intelligence Scale (WISC) score ; | — |
Countries
China
Contacts
Public ContactChen liang
Fudan University HuaShan Hospital
Outcome results
None listed