Refractory Epilepsy
Conditions
Brief summary
Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.
Interventions
DEVICEPINS Vagus Nerve Stimualtor
PINS Vagus Nerve Stimualtor
Sponsors
Beijing Pins Medical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
1. Age 3-6 2. At least 6 seizure per month 3. Refractory Epilepsy 4. In good health except epilepsy 5. Patients or his(her) familyscould understand this method and sign the informed consent 6. Patients with good compliance and could complete postoperative follow-up
Exclusion criteria
1. Results of MRI remind epilepsy caused by intracranial space-occupying lesions 2. The vagus nerve lesion and damage 3. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes，bad health etc, and other surgical contraindication 4. Cann't write the epilepsy diary 5. Participating other clinical trial 6. Cann't complate the operation 7. Complete the postoperative follow-up 8. Cann't complete the promgramming
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in seizure frequency | 12 weeks of stimulation |
Secondary
| Measure | Time frame |
|---|---|
| Changes in seizure frequency | 6、12、24 weeks of stimulation |
| Engel scale description | 6、12、24 weeks of stimulation |
| Changes in the Number of Anti-epileptic Drugs | 6、12、24 weeks of stimulation |
| GESELL mental development scales | 12、24 weeks of stimulation |
Countries
China
Contacts
Primary ContactFumin Jia, PhD
Backup ContactLuming Li, PhD
Outcome results
None listed