Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy
Not Applicable
- Conditions
- Refractory Epilepsy
- Registration Number
- NCT03062514
- Lead Sponsor
- Beijing Pins Medical Co., Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 84
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Changes in seizure frequency 12 weeks of stimulation
- Secondary Outcome Measures
Name Time Method GESELL mental development scales 12、24 weeks of stimulation 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms mediate VNS efficacy in pediatric refractory epilepsy?
How does PINS Vagus Nerve Stimulator compare to standard-of-care antiepileptic drugs in seizure reduction?
Which biomarkers correlate with response to vagus nerve stimulation in intractable epilepsy patients?
What adverse events are associated with PINS VNS in children and how are they managed?
Are there combination therapies or alternative neuromodulation approaches for pediatric refractory epilepsy compared to VNS-PIE?
Trial Locations
- Locations (1)
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Peking University First Hospital🇨🇳Beijing, Beijing, ChinaYuwu JiangContact010-83573228