Medically intractable epilepsy
Conditions
Interventions
treatment group:Implantable Closed-Loop Neurostimulator System, active stimulation after 14 days of surgery.
control group:Implantable Closed-Loop Neurostimulator System, shame stimulation after 14 days of surgery, and active stimulation after 90 days of surgery.
Sponsors
Sanbo Brain Hospital, Capital Medical University; Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
10 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with drug-refractory epilepsy; 2. Aged >= 10 years and <= 70 years, regardless of gender; 3. Epilepsy occurs more than 3 times per month; 4. The number of epileptogenic lesions is less than or equal to 4; 5. The subjects and their families have reasonable expectations that the subjects can record the epilepsy diary alone or with the help of their families; 6. Volunteer to participate in the test and sign a written informed consent; Subjects were evaluated before surgical treatment of epilepsy; 7. Not participating in other clinical trials within three months.
Exclusion criteria
Exclusion criteria: 1. Have received DBS implantation; 2. Active implants such as cardiac pacemakers, defibrillators, cochlear implants, drug infusion pumps, other nerve stimulators, or passive implants that affect the stimulator system; If the patient has an implanted vagus nerve stimulator (VNS) in his body, he can participate in this test after turning off VNS; 3. Patients with neurosurgical contraindications and serious cardio-cerebrovascular diseases; 4. Clinically significant or unstable physical condition (including alcohol and/or drug abuse) or progressive central nervous system disease; 5. Systemic diseases that seriously affect health, such as severe abnormal liver and kidney functions; 6. Women who are pregnant or have intention of pregnancy in the past year, and women in lactation; 7. Subjects judged by the researcher as having poor compliance or not suitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| During the blind vision evaluation period (90 days after surgery), verify that the effective rate of the test group in the treatment of epilepsy is better than that of the control group;The two groups were combined during the open-label evaluation period (180 days after surgery) to verify that the effective rate for the treatment of epilepsy met the requirements of the preset target value.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in response rate between the control group during the blind assessment period and the open-label assessment period for the treatment of epilepsy.;Difference in the rate of response to treatment of epilepsy between the control and experimental groups during the open-label evaluation period.;Evaluation of EEG changes (before and after stimulation);investigator's evaluation of device performance;Subject evaluation of device performance;Changes in quality of life score (QolIE-31) relative to baseline in patients with epilepsy; | — |
Countries
CHina
Contacts
Public ContactZhou Jian
Sanbo Brain Hospital, Capital Medical University
Outcome results
None listed