Pharmacoresistant Epilepsy
Conditions
Interventions
VNS group :vagus nerve stimulation
ANT-DBS group:the anterior nucleus of the thalamus deep brain stimulation
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Patient is between 12 and 60 years of age; 2. Patient has a diagnosis of partial onset seizures and the prior electroencephalography and magnetic resonance imaging studies are consistent with the diagnosis; 3. Patient has at least 4 partial seizure per month during the 3 months before randomization; 4. Persistent seizures despite at least 3 AEDs in single or combination for at least 2 years (pharmacoresistant epilepsy), and the AED regimen is stable for at least 3 months prior to enrolment. 5. Patient is able to provide reliable seizure counts and health outcomes information, and complete study evaluations with minimal assistance; 6. Patient or legal guardian understands study procedures and has voluntarily signed an informed consent.
Exclusion criteria
Exclusion criteria: 1. Patient has had unilateral or bilateral vagotomy; 2. Patient with a progressive neurological, cardiovascular, pulmonary or gastrointestinal condition; 3. Patients with unstable psychiatric condition; 4. Patient with surgical or anesthetic contraindication (e.g. long term of anticoagulant or antiplatelet treatment); 5. Woman of childbearing potential without effective contraception, or pregnant or lactating; 6. Patient currently uses, or expected to use implanted medical device (e.g. cardiac pacemakers, implantable defibrillator, cochlear implant, or spinal cord stimulator); 7. Patient needs frequent magnetic resonance imaging examination during the trial; 8. Patient currently participating in another clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| seizure frequency;seizure frequency reduction rate;AEDs condition;seizure severity; | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life;anxiety;depression; | — |
Countries
China
Contacts
Public ContactKai Zhang
Outcome results
None listed