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Vagus Nerve Stimulation for Pediatric Intractable Epilepsy (VNS-PIE) (NCT03062514)

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.
  • Device: PINS Vagus Nerve Stimualtor
    PINS Vagus Nerve Stimualtor
    Ages eligible for Study
    3 Years to 6 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Age 3-6
    • At least 6 seizure per month
    • Refractory Epilepsy
    • In good health except epilepsy
    • Patients or his(her) familyscould understand this method and sign the informed consent
    • Patients with good compliance and could complete postoperative follow-up
    Exclusion Criteria:
    • Results of MRI remind epilepsy caused by intracranial space-occupying lesions
    • The vagus nerve lesion and damage
    • Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma,mental disease,pepticulcer,diabetes,bad health etc, and other surgical contraindication
    • Cann't write the epilepsy diary
    • Participating other clinical trial
    • Cann't complate the operation
    • Complete the postoperative follow-up
    • Cann't complete the promgramming
    Status:
    not yet recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    31 March, 2017
    Updated:
    19 February, 2017
    Participants:
    84
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