Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial

Neurostimulation for epilepsy refers to the application of electricity to affect the central nervous system, with the goal of reducing seizure frequency and severity. We review the available evidence for the use of neurostimulation to treat pediatric epilepsy, including vagus nerve stimulation (VNS), responsive neurostimulation (RNS), deep brain stimulation (DBS), chronic subthreshold cortical stimulation (CSCS), transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). We consider possible mechanisms of action and safety concerns, and we propose a methodology for selecting between available options. In general, we find neurostimulation is safe and effective, although any high quality evidence applying neurostimulation to pediatrics is lacking. Further research is needed to understand neuromodulatory systems, and to identify biomarkers of response in order to establish optimal stimulation paradigms.

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“…Other studies have shown similar levels of efficacy in pediatric and adult patients in VNS [25]. The rate of response improves over time.…”

Section: Vagus Nerve Stimulationmentioning

confidence: 64%

A Review of Neurostimulation for Epilepsy in Pediatrics

et al. 2019

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“…The Chinese version of GDS was revised by the Chinese Pediatric Association in 1986 and has been shown to have strong internal reliability and validity 21. It has been widely used to evaluate the function of the nervous system22 and to identify whether the nerve muscle or sensory system is defective 23. It is also used to clinically diagnose developmental delay in infants and children 24.…”

Section: Methodsmentioning

confidence: 99%

Association between birth weight and neurodevelopment at age 1–6 months: results from the Wuhan Healthy Baby Cohort

et al. 2020

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ObjectiveThe association between birth weight and infants’ neurodevelopment is not well understood. We aimed to examine the impact of birth weight on neurodevelopment of infants at age 1–6 months using data from the Wuhan Healthy Baby Cohort (WHBC) study.Setting and participantsThis is a prospective cohort study of 4026 infants from the WHBC study who were born at the Women and Children’s Hospital of Wuhan, China between October 2012 and September 2013 and who had complete healthcare records within 6 months after birth. Participants were categorised into three groups according to their birth weight: low birth weight (LBW; birth weight <2500 g), normal birth weight (2500 g ≤ birth weight <4000 g) and macrosomia (birth weight ≥4000 g).Main outcome measuresThe main outcomes were development quotient (DQ) and clinical diagnosis of neurodevelopmental delay. Both adjusted regression coefficients and ORs were estimated for LBW and macrosomia.ResultsOf the 4026 infants, 166 (4.12%) were of LBW and 237 (5.89%) were with macrosomia. Adjusted regression coefficients of LBW and macrosomia for gross motor DQ were −11.18 (95% CI −11.36 to 10.99) and 0.49 (95% CI 0.36 to 0.63), fine motor DQ −6.57 (95% CI −6.76 to −6.39) and −2.73 (95% CI −2.87 to −2.59), adaptability DQ −4.87 (95% CI −5.05 to −4.68) and −1.19 (95% CI −1.33 to −1.05), language DQ −6.23 (95% CI −6.42 to −6.05) and 0.43 (95% CI 0.29 to 0.57), and social behaviour DQ −6.82 (95% CI −7.01 to −6.64) and 1.10 (95% CI 0.96 to 1.24). Adjusted OR of LBW for clinical diagnosis of ‘neurodevelopmental delay’ in gross motor was 2.43 (95% CI 1.65 to 3.60), fine motor 1.49 (95% CI 1.01 to 2.19) and adaptability 1.56 (95% CI 1.06 to 2.31). LBW has no significant effects on ‘neurodevelopmental delay’ in language and social behaviour, and macrosomia has no significant effects on clinical diagnosis of ‘neurodevelopmental delay’ in all domains.ConclusionBoth LBW and macrosomia are associated with infants’ DQ, and LBW increases the risk of being diagnosed with ‘neurodevelopmental delay’ in gross motor, fine motor and adaptability among infants aged 1–6 months.

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“…Potential therapies to address seizures cases in childhood that end in refractory epilepsy envisage nervous vagus stimulation (VNS) to reduce the pro-inflammatory cytokines and neurofeedback protocols to modulate the seizures activity. Current guidelines in VNS, which is an invasive procedure, suggest its usefulness in pediatric patients with intractable epilepsy that are resistant to antiepileptic drugs [ 58 ]. VMS works on stimulation frequency on the left vagus nerve with a specific pulse generator device set to a 20–30 Hz pulse frequency with a pulse width of 250–500 µs [ 59 ].…”

Section: Figure A1mentioning

confidence: 99%

Exploring Inflammatory Status in Febrile Seizures Associated with Urinary Tract Infections: A Two-Step Cluster Approach

et al. 2021

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Background: Urinary tract infections (UTIs) are considered common facilitating factors, along with other infections, in triggering febrile seizures (FS). The main purpose of our study was to identify specific inflammatory patterns of UTI cases from other infections in a specific cluster, using a combination of inflammatory biomarkers to differentiate UTIs from other bacterial diseases triggering FS. Method: This prospective study included a number of 136 patients with 197 distinct FS events, from patients hospitalized in the Pediatric Clinical Hospital Sibiu, among which 10.2% were diagnosed with UTIs. Results: In one-third of the patients with UTIs (20 cases), the symptoms were limited to fever and FS. Using two-step cluster analysis, a distinct UTI inflammatory pattern has emerged: highest platelet values (PLT), median value 331 × 103/mm3 and intermediate C-reactive protein (CRP), median value 15 mg/dL, platelet distribution width (PDW), median value 9.65%, platelet-large cell ratio (P-LCR), median value 14.45%, mean platelet volume (MPV), median value 8.60 fL and neutrophil-to-lymphocyte values (NLR), median value 3.64. Furthermore, higher PDW (median value 12.25%), P-LCR (median value 28.55%), MPV (median value 10.40 fL), CRP (median value 74.00 mg/dL) and NLR values (median value 4.11) were associated mainly (85.7%) with bacterial lower respiratory infections. UTIs were highly unlikely in these patients with significantly increased CRP values and normal values of platelet indices. Conclusions: Considering the nonspecific clinical picture of UTIs at an early age, to optimize the management of FS, a fast diagnosis of UTI is mandatory. The analysis of the inflammatory biomarker clusters (rather than individual parameters) correlated with urine leukocyte and nitrite stick evaluation for specific age groups could help in identifying even oligosymptomatic UTIs patients. The study limitation (20 UTI cases) recommends future multicentric trials on larger datasets to validate the model.

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Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial

Cited by 24 publications

References 69 publications

A Review of Neurostimulation for Epilepsy in Pediatrics

A Review of Neurostimulation for Epilepsy in Pediatrics

Association between birth weight and neurodevelopment at age 1–6 months: results from the Wuhan Healthy Baby Cohort

Exploring Inflammatory Status in Febrile Seizures Associated with Urinary Tract Infections: A Two-Step Cluster Approach

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