Vagus nerve stimulation for drug-resistant epilepsy in children

Vagus nerve stimulation for drug-resistant epilepsy in children indications.

A Novel Scoring System to Evaluate the Efficacy of Vagus Nerve Stimulation for Pediatric Drug-Resistant Epilepsy 1).

A meta-analysis was performed using relevant research from databases such as PubMed, Embase, Cochrane Online Library, and Studies were selected according to predefined inclusion and exclusion criteria. The quality of studies was evaluated by using the Newcastle-Ottawa Scale (NOS) scale. DRE patients with shorter duration of epilepsy may be better candidates for VNS rather than those who are younger at onset and implantation. Several EEG or heart rhythm complexity (HRV) features may have predictive value but more research is needed 2).

Reduced seizure burden and improved QOL were more often observed in patients implanted at a younger age. The shorter duration of epilepsy was significantly associated with QOL improvement. Adverse effects were transient. Overall positive effects showed VNS to be a safe, well-tolerated and effective adjunctive treatment in most severe drug-resistant epilepsy patients. Implantation at a younger age and shorter duration of epilepsy before implantation could be important predictors of a better outcome. 3).

Seven patients who had previously experienced VNS failure underwent ANT-DBS device implantation. VNS was turned off before DBS device implantation. Monthly seizure counts starting from baseline to 12-18 months after DBS were analyzed. Five (71.3%) of the 7 patients experienced a >50% reduction of seizure counts after DBS; 1 responder reached a seizure-free status after DBS therapy. Of the 2 nonresponders, 1 subject showed improvement in seizure strength and duration, which lessened the impact of the seizures on the patient's quality of life. This is the first study in which favorable outcomes of ANT-DBS surgery were observed in individual patients with refractory epilepsy who had not responded to prior VNS. Further studies with a larger number of subjects and longer follow-up period are needed to confirm the feasibility of ANT-DBS in patients who have previously experienced VNS failure 4).

Preliminary evidence suggests that VNS treatment is effective for seizure reduction and mental development in young participants between 3 and 6 years of age who suffer from intractable epilepsy. However, robust clinical evidence for quantifying the difference of the efficacy and safety of VNS treatment in this specific patient population has yet to be reported.

METHODS/DESIGN: A two-armed, multicenter, randomized, double-blind, prospective trial will be carried out to evaluate whether VNS is beneficial and safe for pediatric epilepsy. Pediatric participants aged between 3 to 6 years old with intractable epilepsy will be recruited and randomly assigned to experimental and control groups with a 1:1 allocation using a computer-generating randomization schedule. Before enrollment, informed consent will be signed by the parents of the participants and the study researchers. Participants in the experimental group will receive electrical stimulation over 24 weeks under standard stimulation parameters. Participants in the control group will not receive any stimulation during the 12 weeks of the double-blind period. The guardians of the participants are required to keep a detailed diary to record seizure activity. Outcome assessments including seizure frequency, Gesell Mental Developmental Scale scores, use of antiepileptic drugs and dosages, and adverse events will be collected at baseline, 6, 12, 18 and/or 24 weeks after electrical stimulation is initiated. The effects of treatment will be analyzed with time and treatment group comparisons.

DISCUSSION: This trial will evaluate quantitative differences in efficacy and safety with/without VNS treatment for pediatric participants aged between 3 to 6 years with intractable epilepsy and will explore whether the current age range of VNS therapy can be expanded 5).

Vagus nerve stimulation for drug-resistant epilepsy in children case series

Berardinelli-Seip syndrome, or congenital generalized lipodystrophy type 2 (CGL2), is characterized by a lack of subcutaneous adipose tissue and precocious metabolic syndrome with insulin resistance, resulting in diabetes, dyslipidaemia, hepatic steatosis, cardiomyopathy, and acanthosis nigricans. Most reported mutations are associated with mild, non-progressive neurological impairment. We describe the clinical and EEG data of a patient with progressive myoclonus epilepsy (PME), CGL2, and progressive neurological impairment, carrying a homozygous BSCL2 nonsense mutation. The patient had epilepsy onset at the age of two, characterized by monthly generalized tonic-clonic seizures. By the age of three, he presented with drug-resistant ongoing myoclonic absence seizures, photosensitivity, progressive neurological degeneration, and moderate cognitive delay. Molecular analysis of the BSCL2 gene yielded a homozygous c.(1076dupC) p.(Glu360*) mutation. Application of a vagus nerve stimulator led to temporary improvement in seizure frequency, general neurological condition, and EEG background activity. Specific BSCL2 mutations may lead to a peculiar CGL2 phenotype characterized by PME and progressive neurodegeneration. Application of a vagus nerve stimulator, rarely used for PMEs, may prove beneficial, if only temporarily, for both seizure frequency and general neurological condition 6)

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Jian L, Ju-Bo W, Yu Q, Shou-Ping G. A Novel Scoring System to Evaluate the Efficacy of Vagus Nerve Stimulation for Pediatric Drug-Resistant Epilepsy. J Child Neurol. 2020 Mar;35(4):297-299. doi: 10.1177/0883073819891263. Epub 2019 Dec 16. PubMed PMID: 31838932.
Wang HJ, Tan G, Zhu LN, Chen D, Xu D, Chu SS, Liu L. Predictors of seizure reduction outcome after vagus nerve stimulation in drug-resistant epilepsy. Seizure. 2019 Mar;66:53-60. doi: 10.1016/j.seizure.2019.02.010. Epub 2019 Feb 15. PubMed PMID: 30802843.
Kavčič A, Kajdič N, Rener-Primec Z, Krajnc N, Žgur T. Efficacy and tolerability of vagus nerve stimulation therapy (VNS) in Slovenian epilepsy patients: younger age and shorter duration of epilepsy might result in better outcome. Acta Clin Croat. 2019 Jun;58(2):255-264. doi: 10.20471/acc.2019.58.02.08. PubMed PMID: 31819321; PubMed Central PMCID: PMC6884381.
Park HR, Choi SJ, Joo EY, Seo DW, Hong SB, Lee JI, Hong SC, Lee S, Shon YM. The Role of Anterior Thalamic Deep Brain Stimulation as an Alternative Therapy in Patients with Previously Failed Vagus Nerve Stimulation for Refractory Epilepsy. Stereotact Funct Neurosurg. 2019;97(3):176-182. doi: 10.1159/000502344. Epub 2019 Sep 18. PubMed PMID: 31533117.
Ji T, Yang Z, Liu Q, Liao J, Yin F, Chen Y, Zou L, Li B, Gao Y, Shu X, Huang S, Gao F, Liang J, Lin SF, Peng J, Song S, Wang J, Che C, Sun W, Tian M, Yang L, Hua Y, Hao Y, Cai L, Li L, Jiang Y. 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. Trials. 2019 Jan 14;20(1):44. doi: 10.1186/s13063-018-3087-4. PubMed PMID: 30642370; PubMed Central PMCID: PMC6332620.
Serino D, Davico C, Specchio N, Marras CE, Fioretto F. Berardinelli-Seip syndrome and progressive myoclonus epilepsy. Epileptic Disord. 2019 Feb 1;21(1):117-121. doi: 10.1684/epd.2019.1038. PubMed PMID: 30767895.
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