Drug-resistant Epilepsy
Conditions
Interventions
Phase I: Feasibility Study Group:Intracranial Implantation of Reactive Closed-Loop Electrical Stimulation System and Subsequent Neuromodulation Therapy
Phase II (RCT): Control Group:Implantation of the Responsive Closed-Loop Electrical Stimulation System, Delayed Activation (at Month 6 ) & Subsequent Neuromodulation Therapy
Phase II (RCT): Experimental Group:Intracranial Implantation of Reactive Closed-Loop Electrical Stimulation System and Subsequent Neuromodulation Therapy
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age between 6 and 70 years old (inclusive), gender unrestricted; 2. Diagnosed with drug-resistant epilepsy, focal seizures, and unsuitable or unwilling to undergo surgical resection; 3. No changes in the antiepileptic drug regimen have occurred within the past 3 months (except for acute or intermittent use of benzodiazepines). 4. Three months prior to surgery, the average monthly frequency of disabling epileptic seizures was =3 episodes, with at least 2 seizures per month during these three months; 5. Multidisciplinary preoperative assessment indicates no more than 2 epileptogenic foci. 6. Capable of independently completing or, with family assistance, maintaining a seizure diary. 7. The diagnosis of Drug-resistant epilepsy meeting the criteria for temporal lobe epilepsy, central epilepsy, or epilepsy of multifocal origin. 8. The patient or their family members fully comprehend the treatment, demonstrate good compliance, are able to participate in and complete the entire clinical trial, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with comorbid epileptic pseudoepileptic seizures; 2. Diagnosed with generalized tonic-clonic seizures; 3. Concomitant severe psychiatric or neurological disorders; 4. Coagulation disorders and patients unable to discontinue anticoagulant therapy; 5. Received therapeutic surgical treatment for epilepsy within 6 months prior to implantation; 6. The investigator determines that the local skull condition at the implantation site is unsuitable for this product implantation; 7. The subject has undergone implantation of a vagus nerve stimulator (VNS) or is unwilling to remove the VNS (subjects who are willing to remove the VNS simultaneously with the implantation of this system and have a preoperative VNS treatment suspension of more than 3 months may be included in the study); 8. Other electrical stimulation implant devices are present in the body; 9. Lactating and pregnant women; 10. Participation in other clinical trials within 3 months prior to surgery; 11. Other circumstances deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean monthly seizure frequency during the blinded evaluation period (relative to baseline).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Responder Rate (Open-Label Period);outcome of seizures;Quality of Life Score;Cognitive Assessment Score;Incidence of device deficiencies.;Incidence of adverse events;Incidence of serious adverse events; | — |
Countries
China
Contacts
Public ContactFan Xiaotong
Xuanwu Hospital Capital Medical University
Outcome results
None listed