ABSTRACT
BACKGROUND: Recently, clinical observations reported the potential benefit of vagus nerve stimulation (VNS) for pediatric epilepsy. Transcutaneous auricular vagus nerve stimulation (ta-VNS) is a newer non-invasive VNS, making it more accessible for treating pediatric epilepsy, yet there is limited clinical evidence for its effectiveness. METHODS/DESIGN: A three-center, randomized, parallel, controlled trial will be carried out to evaluate whether ta-VNS improves pediatric epilepsy. Pediatric patients aged 2 to 14 years with epilepsy will be recruited and randomly assigned to transcutaneous auricular vagus nerve stimulation (ta-VNS) group, transcutaneous auricular non-vagus nerve stimulation (tan-VNS) group, and control group with a 1:1: sqrt(2) allocation, as per a computer generated randomization schedule stratified by study center using permuted blocks of random sizes. We will use Zelen's design, in which randomization occurs before informed consent. Patients in the stimulation groups will receive tan-VNS or ta-VNS three times a day for 6 months. Patients in the control group will not be provided with any stimulation during the 6 months. The guardians of the patients are required to keep a detailed diary to record the data. Outcome assessment including seizure frequency, electroencephalogram (EEG), heart rate variability (HRV) analysis, quality of life (QOL) and adverse events will be made at baseline and 2, 4 and 6 months after ta-VNS initiation. The seizure frequency and adverse events will be followed up at 1 year and 1.5 years after ta-VNS initiation. DISCUSSION: Results of this trial will help clarify whether ta-VNS treatment is beneficial for pediatric patients, and will make clear whether the anticonvulsive effect of ta-VNS is correlated with the improvement of sympathovagal imbalance. CLINICAL TRIALS IDENTIFIER: NCT02004340 . Registration date: 13 November 2013.
Subject(s)
Brain/physiopathology , Ear/innervation , Epilepsy/therapy , Vagus Nerve Stimulation/methods , Adolescent , Age Factors , Brain Waves , Child , Child, Preschool , China , Clinical Protocols , Electroencephalography , Epilepsy/diagnosis , Epilepsy/physiopathology , Female , Heart Rate , Humans , Male , Quality of Life , Research Design , Time Factors , Treatment Outcome , Vagus Nerve Stimulation/adverse effectsABSTRACT
This study aimed to investigate the high risk factors, cerebral palsy (CP) subtypes and comorbidities of periventricular leukomalacia (PVL). Based on treatment conditions at a specialist hospital, a cross-sectional clinical study and retrospective analysis of computed tomography and magnetic resonance imaging examinations was conducted to evaluate the risk factors, subtypes and comorbidities of CP in children with PVL. Among the 408 children with PVL, 8.58% were born with a weight of ≤1,500 g and 44.36% were born with a weight of ≥2,500 g. In addition, 36.76% of these children had a gestational age of ≤32 weeks and 37.75% had a gestational age of ≥37 weeks. The proportion of the children born with various high risk factors was 95.59%, including perinatal infections and hypoxia. Severe PVL was observed in preterm infants (63.41% with a gestational age of <28 weeks and 21.95% with a gestational age of 28-30 weeks) and low-birth weight infants, which were prone to quadriplegia (43.90%). The common comorbidities included visual and auditory disorders, epilepsy, mental retardation and language barriers. Visual and auditory disorders (26.96%) were the most common comorbidities. PVL was identified primarily in premature and low-birth weight infants. The degree of PVL was found to be negatively correlated with gestational age and birth weight. The degree of PVL in the full-term infants correlated with exposure to infections or hypoxia. Quadriplegia is common among the various subtypes of CP. Visual and hearing disorders are the most common comorbidities of CP; these comorbidities occurred most frequently with quadriplegia.
