Medically intractable epilepsy
Conditions
Interventions
Experimental group:Implantable closed-loop neural stimulator system for chronic subthreshold electrical stimulation in the treatment of drug-resistant epilepsy
Sponsors
The First Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 50 Years
Inclusion criteria
Inclusion criteria: ? Patients with drug-resistant epilepsy; ?Age =6 years old, and =50 years old, gender is not limited; ? Subjects were evaluated before surgical treatment of epilepsy; ?Seizures occur more than 3 times per month, including focal seizures and/or secondary general tonic-clonic seizures; ? the subjects have good compliance and can cooperate with the whole clinical trial; ? no other clinical trials within three months; ?The subject and family members have a reasonable expectation that the subject will be able to keep a seizure diary alone or with the help of family members; ? Voluntarily participate in this experiment and sign a written informed consent; ? No contraindications for neurosurgery.
Exclusion criteria
Exclusion criteria: ? Has been diagnosed with idiopathic generalized epilepsy. ?Have received DBS implantation, or have received surgical treatment other than DBS, such as stereotactic mutilation, cell transplantation, gamma knife, etc. ? There are contraindications of neurosurgery and serious cardiovascular and cerebrovascular diseases. ?Active implants in the body such as pacemakers, defibrillators, cochlear implants, drug infusion pumps, implantable vagus nerve stimulators (VNS), other nerve stimulators, etc. (whether turned on or not); Or passive implants that affect the stimulator system. ?A clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive central nervous system disorder. ?Systemic diseases with severe abnormalities of liver and kidney function that seriously affect health. ?Participants who have participated in other clinical trials within three months. ?Women who are pregnant or have pregnancy intention for nearly one year, or breastfeeding women. ? The investigator determined that the subjects had poor compliance or were not suitable to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction rate of seizure frequency compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the changes in the number of epileptic discharges in the electroencephalogram with the baseline and evaluate the improvement of the electroencephalogram.;The relative baseline changes of the Quality of Life Assessment Scale-31 (QOLIE-31) for postoperative epilepsy patients.;The relative baseline changes of the Hamilton Depression Scale and Hamilton Anxiety Scale in postoperative epilepsy patients.;The relative baseline changes in the types and doses of antiepileptic drugs taken.; | — |
Countries
China
Contacts
Public ContactTian Shujuan
The First Hospital of Hebei Medical University
Outcome results
None listed