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Abstract Background Attention Deficit/Hyperactivity Disorder (ADHD), if severe, is usually treated with stimulant or non-stimulant medication. However, users prefer non-drug treatments due to side effects. Alternative non-medication treatments have so far only shown modest effects. External trigeminal nerve stimulation (eTNS) is a minimal risk, non-invasive neuromodulation device, targeting the trigeminal system. It was approved for ADHD in 2019 by the USA Food and Drug administration (FDA) based on a small proof of concept randomised controlled trial (RCT) in 62 children with ADHD showing improvement of ADHD symptoms after 4 weeks of nightly real versus sham eTNS with minimal side effects. We present here the protocol of a larger confirmatory phase IIb study testing efficacy, longer-term persistency of effects and underlying mechanisms of action. Methods A confirmatory, sham-controlled, double-blind, parallel-arm, multi-centre phase IIb RCT of 4 weeks of eTNS in 150 youth with ADHD, recruited in London, Portsmouth, and Southampton, UK. Youth with ADHD will be randomized to either real or sham eTNS, applied nightly for 4 weeks. Primary outcome is the change in the investigator-administered parent rated ADHD rating scale. Secondary outcomes are other clinical and cognitive measures, objective hyperactivity and pupillometry measures, side effects, and maintenance of effects over 6 months. The mechanisms of action will be tested in a subgroup of 56 participants using magnetic resonance imaging (MRI) before and after the 4-week treatment. Discussion This multi-centre phase IIb RCT will confirm whether eTNS is effective in a larger age range of children and adolescents with ADHD, whether it improves cognition and other clinical measures, whether efficacy persists at 6 months and it will test underlying brain mechanisms. The results will establish whether eTNS is effective and safe as a novel non-pharmacological treatment for ADHD. Trial registration: ISRCTN82129325 on 02/08/2021, https://doi.org/10.1186/ISRCTN82129325 .

Background: Attention Deficit/Hyperactivity Disorder (ADHD), if severe, is usually treated with stimulant or non-stimulant medication. However, users prefer non-drug treatments due to side effects. Alternative non-medication treatments have so far only shown modest effects. External trigeminal nerve stimulation (eTNS) is a minimal risk, non-invasive neuromodulation device, targeting the trigeminal system. It was approved for ADHD in 2019 by the USA Food and Drug administration (FDA) based on a small proof of concept randomised controlled trial (RCT) in 62 children with ADHD showing improvement of ADHD symptoms after 4 weeks of nightly real versus sham eTNS with minimal side effects. We present here the protocol of a larger confirmatory phase IIb study testing efficacy, longer-term persistency of effects and underlying mechanisms of action. Methods: A confirmatory, sham-controlled, double-blind, parallel-arm, multi-centre phase IIb RCT of 4 weeks of eTNS in 150 youth with ADHD, recruited in London, Portsmouth, and Southampton, UK. Youth with ADHD will be randomized to either real or sham eTNS, applied nightly for 4 weeks. Primary outcome is the change in the investigator-administered parent rated ADHD rating scale. Secondary outcomes are other clinical and cognitive measures, objective hyperactivity and pupillometry measures, side effects, and maintenance of effects over 6 months. The mechanisms of action will be tested in a subgroup of 56 participants using magnetic resonance imaging (MRI) before and after the 4-week treatment. Discussion: This multi-centre phase IIb RCT will confirm whether eTNS is effective in a larger age range of children and adolescents with ADHD, whether it improves cognition and other clinical measures, whether efficacy persists at 6 months and it will test underlying brain mechanisms. The results will establish whether eTNS is effective and safe as a novel non-pharmacological treatment for ADHD. Trial registration: ISRCTN82129325 on 02/08/2021, https://doi.org/10.1186/ISRCTN82129325. [ABSTRACT FROM AUTHOR]

Uno de los principales objetivos del T-MEC es la “legitimación” de las relaciones laborales de México bajo los nuevos criterios para la fuerza de trabajo mexicano. Las disposiciones laborales del T-MEC exigen la creación de instituciones clave financiadas por el gobierno de Estados Unidos (EU) y, sobre todo, México. Los asuntos relacionados con la implementación de la reforma laboral de México de 2019, la cual incorpora diversos elementos novedosos en torno a procesos de ratificación de contratos colectivos de trabajo y titularidad sindical, en la cual se prioriza el ejercicio de votación libre y secreto, ahora es oficio del Representante Comercial de Estados Unidos (United States Trade Representative, -USTR). Afirma el gobierno de EU que tiene el poder de monitorear los derechos laborales de México, lo que permite que el USTR actúe sin el consentimiento de México. Irónicamente, sindicatos de EU están abogando por un “salario digno” para los obreros mexicanos para evitar o disminuir la desindustrialización. La imposición desde afuera de un mejoramiento en los salarios miserables es algo inimaginable para la oligarquía mexicana y las empresas transnacionales de EU con fábricas y minas en México.

Purpose Of Review: The past two decades has seen an influx of noninvasive neuromodulation devices aimed at treatment of various primary headache disorders, including cluster headache and migraine. This narrative review is to summarize the current options in noninvasive neuromodulation in migraine.Recent Findings: A variety of noninvasive neuromodulation devices have been FDA cleared and marketed for use in migraine, including single-pulse transcranial magnetic stimulation (sTMS), noninvasive vagal nerve stimulators (nVNS), and external trigeminal nerve stimulators (eTNS). Newer devices include peripheral electrical stimulation devices (PES), caloric stimulation, and others. Each has varying levels of evidence supporting its use in migraine, tolerability profiles, and access issues. Noninvasive neuromodulation devices can be beneficial when used in patients with migraine, with minimal side effects. As more devices are developed, approved, and marketed in the future, rigorous research on efficacy and safety remain a top priority. [ABSTRACT FROM AUTHOR]

Purpose: External trigeminal nerve stimulation (eTNS) is a non-invasive neurostimulation treatment for drug refractory epilepsy. There is limited published data on the efficacy of eTNS and none relating to quality of life, mood or effect on sleep quality.Methods: We audited its use in 42 patients with drug refractory epilepsy at a tertiary centre, between 02/04/2013 and 14/08/2015. Data was collected on seizure frequency, quality of life, mood and sleep quality before and after initiating treatment.Results: 45% of patients continued to use eTNS at the end of the audit period. We observed a significant improvement in both quality of life and mood in those without intellectual disabilities. A decrease in seizures (-11.0%, min -60, max +65) was observed though this did not reach statistical significance with the relatively small numbers available for analysis.Conclusion: Further controlled studies are required to confirm the efficacy of eTNS. However, as it is non-invasive, flexible and safe eTNS can be considered as an option in patients with drug refractory epilepsy. [ABSTRACT FROM AUTHOR]