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1.
J Clin Neurosci ; 68: 13-19, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31375306

RESUMO

Implantable neurostimulation devices provide a direct therapeutic link to the nervous system and can be considered brain-computer interfaces (BCI). Under this definition, BCI are not simply science fiction, they are part of existing neurosurgical practice. Clinical BCI are standard of care for historically difficult to treat neurological disorders. These systems target the central and peripheral nervous system and include Vagus Nerve Stimulation, Responsive Neurostimulation, and Deep Brain Stimulation. Recent advances in clinical BCI have focused on creating "closed-loop" systems. These systems rely on biomarker feedback and promise individualized therapy with optimal stimulation delivery and minimal side effects. Success of clinical BCI has paralleled research efforts to create BCI that restore upper extremity motor and sensory function to patients. Efforts to develop closed loop motor/sensory BCI is linked to the successes of today's clinical BCI.


Assuntos
Interfaces Cérebro-Computador/tendências , Estimulação Encefálica Profunda/tendências , Doenças do Sistema Nervoso/terapia , Estimulação do Nervo Vago/tendências , Estimulação Encefálica Profunda/instrumentação , Estimulação Encefálica Profunda/métodos , Humanos , Estimulação do Nervo Vago/instrumentação , Estimulação do Nervo Vago/métodos
2.
World Neurosurg ; 130: e839-e845, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31295613

RESUMO

BACKGROUND: Risk factors for infection after vagus nerve stimulation (VNS) device implantation represent an important issue but remain unclear. We hypothesized that specific risk factors for infection would be associated with VNS device implantation. This study reviewed patients with epilepsy who underwent VNS device implantation and undertook a statistical analysis of risk factors for surgical site infection (SSI). METHODS: We reviewed all medical records for patients who underwent VNS therapy in our facility between August 2011 and May 2018. Age, sex, height, body weight, body mass index (BMI), intelligence quotient (IQ), surgical incision opening time, blood loss, epilepsy classification, activities of daily living, and generator replacement were statistically compared between cases with and without SSI. RESULTS: We performed 208 VNS device implantation surgeries at our facility during the study period. Among these, 150 patients underwent initial implantation, 56 patients underwent first generator replacement, and 2 patients underwent second replacement. Six patients (2.7%) with initial implantation and 3 patients (5.4%) with first replacement showed SSI. Low BMI was a risk factor for infection at initial implantation (P < 0.0012) using a BMI within 1.78 kg/m2 of the cutoff for being underweight (100% sensitivity, 25% specificity). Low IQ (P = 0.0015) was also a risk factor for SSI. CONCLUSIONS: This study identified low BMI and low IQ at initial implantation as risk factors for infection.


Assuntos
Índice de Massa Corporal , Eletrodos Implantados/efeitos adversos , Inteligência , Infecção da Ferida Cirúrgica/diagnóstico , Estimulação do Nervo Vago/efeitos adversos , Adolescente , Adulto , Criança , Pré-Escolar , Estudos Transversais , Seguimentos , Humanos , Lactente , Inteligência/fisiologia , Fatores de Risco , Infecção da Ferida Cirúrgica/etiologia , Resultado do Tratamento , Estimulação do Nervo Vago/instrumentação , Adulto Jovem
3.
Dermatol Surg ; 45(10): 1228-1236, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31318829

RESUMO

BACKGROUND: In dermatologic and procedural surgery settings, there are commonly encountered devices in patients. Safe surgical planning requires familiarity with these devices. OBJECTIVE: To review the current implanted devices in patients and recommendations for surgical planning around these devices. METHODS AND MATERIALS: A comprehensive review using PubMed and published device recommendations was performed, searching for those most relevant to dermatologic surgery. RESULTS: Devices such as pacemakers and implantable cardiac defibrillators, deep brain stimulators, cochlear implants, and various nerve stimulators are potential devices that may be encountered in patients and specific recommendations exist for each of these devices. CONCLUSION: Dermatologic surgeons' knowledge of implanted devices in patients is paramout to safe surgical procedures.


Assuntos
Procedimentos Cirúrgicos Dermatológicos/métodos , Planejamento de Assistência ao Paciente , Neoplasias Cutâneas/cirurgia , Implantes Cocleares/efeitos adversos , Estimulação Encefálica Profunda/instrumentação , Desfibriladores Implantáveis/efeitos adversos , Humanos , Neuroestimuladores Implantáveis/efeitos adversos , Marca-Passo Artificial/efeitos adversos , Estimulação do Nervo Vago/instrumentação
4.
Neurotherapeutics ; 16(2): 369-380, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-31062294

RESUMO

Implantable neural stimulators represent an advanced treatment adjunct to medication for pharmacoresistant epilepsy and alternative for patients that are not good candidates for resective surgery. Three treatment modalities are currently FDA-approved: vagus nerve stimulation, responsive neurostimulation, and deep brain stimulation. These devices were originally trialed in very similar patient populations with focal epilepsy, but head-to-head comparison trials have not been performed. As such, device selection may be challenging due to large overlaps in clinical indications and efficacy. Here we will review the data reported in the original pivotal clinical trials as well as long-term experience with these technologies. We will highlight differences in their features and mechanisms of action which may help optimize device selection on a case-by-case basis.


Assuntos
Estimulação Encefálica Profunda/instrumentação , Epilepsia/terapia , Neuroestimuladores Implantáveis , Estimulação do Nervo Vago/instrumentação , Humanos
5.
NASN Sch Nurse ; 34(5): 257-261, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30920895

RESUMO

The Specialized Health Needs Interagency Collaboration (SHNIC) program at the Kennedy Krieger Institute is a community-based program that provides on-site training and technical assistance to safely manage the integration of children with special health needs into educational and community settings. SHNIC frequently receives seizure education requests throughout the school year, specifically regarding vagus nerve stimulation. Vagus nerve stimulation involves an implanted medical device used to deliver electrical pulses to the vagus nerve for additional seizure management. The school nurse needs to understand the purpose and function of the hidden medical device, including the parameters for use of the device and magnet, safety considerations, and side effects. SHNIC has developed educational materials specific to vagus nerve stimulation to aid the school nurse in providing staff training, developing care plans, and creating a safe school experience for students with special health needs.


Assuntos
Convulsões/prevenção & controle , Estimulação do Nervo Vago/instrumentação , Humanos , Serviços de Enfermagem Escolar , Estimulação do Nervo Vago/enfermagem
6.
Epilepsy Res ; 153: 66-67, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30910314

RESUMO

The Fourteenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XIV) took place in Madrid, Spain from May 13th to 16th 2018. Again, presentations on new medical devices and neuromodulation and discussions on device-related regulatory aspects were included in the programme. The virtual special issue on "neuromodulation" summarises the presentations focusing firstly, on the pre-clinical developments and the difficulties of clinical trial designs for neuromodulatory therapies, including vagus nerve stimulation (VNS) and Brain-Responsive Neurostimulation (RNS), and the use of transcutaneous vagus nerve stimulation (tVNS) as a potential screening tool for determining the efficacy of neuromodulatory treatments in individual patients; secondly, on wearable devices for seizure monitoring through indices of peripheral sympathetic nervous activity, the use of such devices in combination with biofeedback for the treatment of epilepsy, and its potential for improving epilepsy specialist services, particularly in remote areas.


Assuntos
Anticonvulsivantes/uso terapêutico , Epilepsia/terapia , Estimulação do Nervo Vago/métodos , Dispositivos Eletrônicos Vestíveis , Animais , Ensaios Clínicos como Assunto , Congressos como Assunto , Humanos , Espanha , Estimulação do Nervo Vago/instrumentação
7.
Physiology (Bethesda) ; 34(2): 150-162, 2019 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-30724129

RESUMO

Autonomic nerves are attractive targets for medical therapies using electroceutical devices because of the potential for selective control and few side effects. These devices use novel materials, electrode configurations, stimulation patterns, and closed-loop control to treat heart failure, hypertension, gastrointestinal and bladder diseases, obesity/diabetes, and inflammatory disorders. Critical to progress is a mechanistic understanding of multi-level controls of target organs, disease adaptation, and impact of neuromodulation to restore organ function.


Assuntos
Sistema Nervoso Autônomo/fisiopatologia , Terapia por Estimulação Elétrica/métodos , Cardiopatias/terapia , Animais , Diabetes Mellitus/fisiopatologia , Diabetes Mellitus/terapia , Terapia por Estimulação Elétrica/instrumentação , Gastroenteropatias/fisiopatologia , Gastroenteropatias/terapia , Cardiopatias/fisiopatologia , Humanos , Inflamação/fisiopatologia , Inflamação/terapia , Obesidade/fisiopatologia , Obesidade/terapia , Estimulação da Medula Espinal/instrumentação , Estimulação da Medula Espinal/métodos , Doenças da Bexiga Urinária/fisiopatologia , Doenças da Bexiga Urinária/terapia , Estimulação do Nervo Vago/instrumentação , Estimulação do Nervo Vago/métodos
8.
Emerg Med J ; 36(1): 27-31, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30504456

RESUMO

BACKGROUND: The Valsalva manoeuvre (VM) is used to treat supraventricular tachycardia (SVT) by inducing a vagal response (drop in HR). There is debate as to the best position in which to carry out the VM and how the strain should be delivered in practice. We aimed to compare vagal responses induced with supine and modified VMs using strains delivered with a standardised manometer or novel Valsalva Assist Device (VAD), a simple device to provide resistance to exhalation. METHODS: We conducted a repeated measures randomised trial of four VMs (two supine VM and two modified VMs), in healthy adult volunteers, with strains delivered using an adapted sphygmomanometer (manometer) or a VAD. Changes in HR, pressure and duration of strain and adverse events were monitored and compared between the techniques and devices. The trial was approved by the University of Exeter Medical School Research ethics committee. RESULTS: 75 healthy participants aged 19-55 years were recruited over a 4-month period. A mixed-effects linear regression showed the modified VM resulted in a 3.8 beats per min (bpm) greater drop in HR compared with the supine VM (p=0.002, 95% CI 2.2 to 5.4). VM strains produced by the VAD were of a similar pressure but of slightly shorter duration and resulted in a 1.9 bpm smaller drop in HR compared with the manometer (p=0.01, 95% CI 0.4 to 3.4). There were no differences in adverse events. CONCLUSIONS: Modified VM was associated with a greater drop in HR than a supine VM with no increase in adverse events in healthy volunteers. The VAD can be used to safely generate the recommended VM strain pressure, but produced a smaller drop in HR compared with a manometer and requires modification to enable the recommended strain duration to be achieved consistently. TRIAL REGISTRATION NUMBER: NCT03298880.


Assuntos
Desenho de Equipamento/normas , Frequência Cardíaca/fisiologia , Estimulação do Nervo Vago/instrumentação , Manobra de Valsalva/fisiologia , Adulto , Feminino , Voluntários Saudáveis , Humanos , Masculino , Pessoa de Meia-Idade , Decúbito Dorsal/fisiologia , Nervo Vago/fisiologia , Estimulação do Nervo Vago/métodos
9.
Neuromodulation ; 22(5): 564-572, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30288866

RESUMO

OBJECTIVES: The primary objective of this study was to explore the impact of noninvasive Vagal Nerve Stimulation (nVNS) on brain electrophysiology, as assessed through spontaneous resting-state EEG and stimulus-driven event-related potentials (ERPs). METHODS: A hand-held transcutaneous stimulator was placed on the neck over the main branch of the left vagus (active condition) or more laterally over neck muscles (sham condition), with two 120-sec long bursts of stimulation applied over a five-minute period. For each of eight neurotypical subjects, prior to stimulation, and then again beginning at 15, 120, and 240 min post-stimulation, ten minutes of background EEG data were collected, along with a series of ERPs-N100 auditory sensory-gating; the N1/P2 loudness dependent auditory evoked responses (LDAER); mismatch negativity; P300a; and P300b. Each subject participated in active and sham stimulation sessions. RESULTS: Brief nVNS had a significant (p < 0.05), and in some cases prolonged (>2 hours), impact on the spontaneous EEG (decreased theta and alpha, and increased beta and gamma), and on sensory gating, LDAER, and P300b evoked responses. Based on prior literature, these specific observations may reflect nVNS-induced modulation of particular neurotransmitter systems including those for GABA (gamma power and frequency); acetylcholine (sensory gating); serotonin (LDAER); and noradrenaline (P300b). CONCLUSIONS: Brief nVNS leads to changes in a sub-set of resting-state and event-related electrophysiologic indices of brain activity. These changes are believed to be mediated by vagal afferent projections to the nucleus of the solitary tract, which in turn regulates several neurotransmitter systems through known direct and indirect neuroanatomic pathways.


Assuntos
Encéfalo/fisiologia , Eletroencefalografia/métodos , Potenciais Evocados/fisiologia , Estimulação do Nervo Vago/métodos , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estimulação do Nervo Vago/instrumentação , Adulto Jovem
10.
Neuromodulation ; 22(5): 630-637, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30549376

RESUMO

OBJECTIVES: Until now, the vagus nerve stimulation (VNS) treatment in epilepsy has consisted of two different modes: normal and magnet stimulation. A new vagus nerve stimulator model (106 AspireSR®, LivaNova, Houston, TX, USA) also allows automatic stimulation (AutoStim). The purpose of this study is to examine the effect of autostimulation on seizure frequencies together with energy consumption. MATERIALS AND METHODS: The study material consisted of 14 patients whose former stimulator model (102/103) was replaced with model 106. We calculated the theoretical charge (Q) in Coulombs for one day in both of those groups. We evaluated the follow-up data of the patients' seizure counts, with a mean follow-up time of 18.1 months (SD 8.1). RESULTS: The total charge, "VNS dose," was reduced with model 106 in comparison with models 102 or 103 (p = 0.001, Mann-Whitney test). The average charge (Qtotal ) for one day with AutoStim was 142.56 mC; without AutoStim, it was 321.09 mC. We were able to assess seizure diaries in 11 out of 14 patients. Four patients (36%) had >50% seizure reduction and two patients (18%) experienced a reduction in seizure severity with VNS with autostimulation. Five patients (46%) remained unchanged. In three out of four patients with improved seizure control, the duty cycle was maintained at the original level. The patients whose duty cycle was modified for a more prolonged OFF-time had unchanged seizure frequencies. CONCLUSION: VNS with AutoStim achieves maintenance of prior-established seizure control with markedly less energy consumption and can also improve seizure control as compared to former stimulator model.


Assuntos
Epilepsia/diagnóstico , Epilepsia/terapia , Estimulação Elétrica Nervosa Transcutânea/métodos , Estimulação do Nervo Vago/métodos , Adolescente , Adulto , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Estimulação Elétrica Nervosa Transcutânea/instrumentação , Resultado do Tratamento , Estimulação do Nervo Vago/instrumentação
11.
Epilepsy Behav ; 88S: 25-32, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30558717

RESUMO

Epilepsy is often associated with comorbid psychiatric illnesses that can significantly impact its long-term course. The most frequent of these psychiatric comorbidities is major depressive disorder, which affects an estimated 40% of patients with epilepsy. Many patients are underdiagnosed or undertreated, yet managing their mood symptoms is critical to improving their outcomes. When conventional psychiatric treatments fail in the management of depression, neuromodulation techniques may offer promise, including electroconvulsive therapy (ECT), vagus nerve stimulation (VNS), and repetitive transcranial magnetic stimulation (rTMS), as discussed in this review. "This article is part of the Supplement issue Neurostimulation for Epilepsy."


Assuntos
Transtorno Depressivo Maior/terapia , Epilepsia Resistente a Medicamentos/terapia , Eletroconvulsoterapia/métodos , Neuroestimuladores Implantáveis , Ensaios Clínicos como Assunto/métodos , Transtorno Depressivo Maior/epidemiologia , Transtorno Depressivo Maior/psicologia , Epilepsia Resistente a Medicamentos/epidemiologia , Epilepsia Resistente a Medicamentos/psicologia , Eletroconvulsoterapia/instrumentação , Humanos , Psicoterapia/instrumentação , Psicoterapia/métodos , Estimulação Magnética Transcraniana/instrumentação , Estimulação Magnética Transcraniana/métodos , Estimulação do Nervo Vago/instrumentação , Estimulação do Nervo Vago/métodos
12.
Nat Commun ; 9(1): 5349, 2018 12 17.
Artigo em Inglês | MEDLINE | ID: mdl-30559435

RESUMO

In vivo vagus nerve stimulation holds great promise in regulating food intake for obesity treatment. Here we present an implanted vagus nerve stimulation system that is battery-free and spontaneously responsive to stomach movement. The vagus nerve stimulation system comprises a flexible and biocompatible nanogenerator that is attached on the surface of stomach. It generates biphasic electric pulses in responsive to the peristalsis of stomach. The electric signals generated by this device can stimulate the vagal afferent fibers to reduce food intake and achieve weight control. This strategy is successfully demonstrated on rat models. Within 100 days, the average body weight is controlled at 350 g, 38% less than the control groups. This work correlates nerve stimulation with targeted organ functionality through a smart, self-responsive system, and demonstrated highly effective weight control. This work also provides a concept in therapeutic technology using artificial nerve signal generated from coordinated body activities.


Assuntos
Regulação do Apetite , Ingestão de Alimentos , Obesidade/terapia , Estômago/fisiologia , Estimulação do Nervo Vago/instrumentação , Estimulação do Nervo Vago/métodos , Nervo Vago/metabolismo , Células 3T3 , Animais , Linhagem Celular , Camundongos , Peristaltismo/fisiologia , Ratos , Ratos Sprague-Dawley
13.
Am J Manag Care ; 24(24 Suppl): S507-S516, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30543268

RESUMO

GammaCore was cleared by the FDA for the acute treatment of episodic migraine and episodic cluster headache and has 5 Conformité Européenne marks. Data indicate that gammaCore treatment is both safe and effective as an acute treatment for migraine. Current reimbursement policies need to be updated based on the growing body of evidence to reflect the established status of gammaCore that is no longer experimental. GammaCore provides substantial value to patients and to payers for consideration for pay-for-performance health coverage strategies and policies.


Assuntos
Cefaleia Histamínica/terapia , Transtornos de Enxaqueca/terapia , Estimulação do Nervo Vago/instrumentação , Humanos , Mecanismo de Reembolso , Estados Unidos
14.
Am J Manag Care ; 24(24 Suppl): S517-S526, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30543269

RESUMO

A patient audit was conducted in the UK to evaluate the impact of gammaCore use in multimorbidity patients on quality of life and healthcare resources utilization measures. A total of 233 patients were enrolled and their data was examined over a 1-year period after their gammaCore prescription. Of these patients, 132 (56%) had primary headache disorders while 101 (44%) were patients without a headache disorder (nonheadache patients). The mean age was 49 years, 169 (72%) were female, the mean number of comorbid conditions was 3.1, and the mean baseline EQ-5D score was 0.581. The mean paired difference in EQ-5D index for persistent gammaCore users (ie patients who used gammaCore for at least 40 weeks) was +0.156 at week 40. The mean percentage reductions in number of general practice consults (doctor's office appointments) was -28.5% from baseline mean of 7.31 and, 40.0% from baseline mean of 3.52 for medical codes used. This evidence demonstrates that a significant proportion of these multimorbidity patients on gammaCore remained compliant with the prescribed treatment regimen for an extended period. GammaCore use in multimorbidity patients may be associated with lower costs of care and provide opportunities for pay-for-performance coverage policies.


Assuntos
Cefaleia Histamínica/terapia , Transtornos de Enxaqueca/terapia , Atenção Primária à Saúde , Qualidade de Vida , Estimulação do Nervo Vago/instrumentação , Adolescente , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Multimorbidade , Aceitação pelo Paciente de Cuidados de Saúde , Medidas de Resultados Relatados pelo Paciente , Reino Unido
15.
Am J Manag Care ; 24(24 Suppl): S527-S533, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30543270

RESUMO

Migraine affects 15% of the population in the United States and is associated with comorbidities, with an estimated economic burden of $78 billion annually. GammaCore is used adjunctively with current standard of care and abortive medications and has shown to be superior in acute treatment of episodic migraine compared to sham. However, the economic impact has not been characterized for this indication. We conducted a cost-effectiveness analyses for 2 hypothetical scenarios: a primary model for treatment options gammaCore plus standard of care compared to standard of care alone for acute treatment of migraine; and a secondary model for treatment sequence strategies where acute treatment with gammaCore or standard of care each prior to erenumab prevention compared to initiating erenumab prevention with no prerequisite. The time horizon for the model is 1 year, using a payer perspective. GammaCore plus standard of care arm was dominant over standard of care alone in the primary model. The mean costs for gammaCore plus standard of care arm and standard of care individually were $9678 and $10,010, respectively. The mean quality of life-years for gammaCore plus standard of care arm and standard of care alone were 0.67, and 0.63, respectively. For the secondary model, the mean costs for gammaCore followed by erenumab, standard of care followed by erenumab and initiating with erenumab with no prior gammaCore or standard of care treatment were $10,678, $11,583, and $13,766. The corresponding mean for quality of life-years were 0.70, 0.67, and 0.65, respectively. For gammaCore dominance, ie, in this scenario, patients were more satisfied on gammaCore, to not need erenumab for preventative therapy lower mean costs and represents savings for payers. This was driven by efficacy, improvement in quality of life, and reduction in costs of care associated with successful treatment of migraine attacks. These findings provide new economic evidence to support value forcoverage for gammaCore.


Assuntos
Cefaleia Histamínica/terapia , Análise Custo-Benefício , Transtornos de Enxaqueca/terapia , Estimulação do Nervo Vago/economia , Estimulação do Nervo Vago/instrumentação , Anticorpos Monoclonais Humanizados/economia , Anticorpos Monoclonais Humanizados/uso terapêutico , Antagonistas do Receptor do Peptídeo Relacionado ao Gene de Calcitonina/economia , Antagonistas do Receptor do Peptídeo Relacionado ao Gene de Calcitonina/uso terapêutico , Ensaios Clínicos como Assunto , Humanos , Modelos Econômicos , Qualidade de Vida , Estados Unidos
16.
J Headache Pain ; 19(1): 101, 2018 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-30382909

RESUMO

BACKGROUND: Non-invasive vagus nerve stimulation (nVNS) has been shown to be practical, safe, and well tolerated for treating primary headache disorders. The recent multicenter, randomized, double-blind, sham-controlled PRESTO trial provided Class I evidence that for patients with episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free 2 h post stimulation. We report additional pre-defined secondary and other end points from PRESTO that demonstrate the consistency and durability of nVNS efficacy across a broad range of outcomes. METHODS: After a 4-week observation period, 248 patients with episodic migraine with/without aura were randomly assigned to acute treatment of migraine attacks with nVNS (n = 122) or a sham device (n = 126) during a double-blind period lasting 4 weeks (or until the patient had treated 5 attacks). All patients received nVNS therapy during the subsequent 4-week/5-attack open-label period. RESULTS: The intent-to-treat population consisted of 243 patients. The nVNS group (n = 120) had a significantly greater percentage of attacks treated during the double-blind period that were pain-free at 60 (P = 0.005) and 120 min (P = 0.026) than the sham group (n = 123) did. Similar results were seen for attacks with pain relief at 60 (P = 0.025) and 120 min (P = 0.018). For the first attack and all attacks, the nVNS group had significantly greater decreases (vs sham) in pain score from baseline to 60 min (P = 0.029); the decrease was also significantly greater for nVNS at 120 min for the first attack (P = 0.011). Results during the open-label period were consistent with those of the nVNS group during the double-blind period. The incidence of adverse events (AEs) and adverse device effects was low across all study periods, and no serious AEs occurred. CONCLUSIONS: These results further demonstrate that nVNS is an effective and reliable acute treatment for multiple migraine attacks, which can be used safely while preserving the patient's option to use traditional acute medications as rescue therapy, possibly decreasing the risk of medication overuse. Together with its practicality and optimal tolerability profile, these findings suggest nVNS has value as a front-line option for acute treatment of migraine. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02686034 .


Assuntos
Transtornos de Enxaqueca/diagnóstico , Transtornos de Enxaqueca/terapia , Manejo da Dor/métodos , Estimulação do Nervo Vago/métodos , Adolescente , Adulto , Idoso , Analgésicos/uso terapêutico , Método Duplo-Cego , Feminino , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Transtornos de Enxaqueca/epidemiologia , Manejo da Dor/instrumentação , Resultado do Tratamento , Estimulação do Nervo Vago/instrumentação , Adulto Jovem
17.
J Headache Pain ; 19(1): 98, 2018 Oct 19.
Artigo em Inglês | MEDLINE | ID: mdl-30340460

RESUMO

BACKGROUND: The PRESTO study of non-invasive vagus nerve stimulation (nVNS; gammaCore®) featured key primary and secondary end points recommended by the International Headache Society to provide Class I evidence that for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free 2 h post stimulation. Here, we examined additional data from PRESTO to provide further insights into the practical utility of nVNS by evaluating its ability to consistently deliver clinically meaningful improvements in pain intensity while reducing the need for rescue medication. METHODS: Patients recorded pain intensity for treated migraine attacks on a 4-point scale. Data were examined to compare nVNS and sham with regard to the percentage of patients who benefited by at least 1 point in pain intensity. We also assessed the percentage of attacks that required rescue medication and pain-free rates stratified by pain intensity at treatment initiation. RESULTS: A significantly higher percentage of patients who used acute nVNS treatment (n = 120) vs sham (n = 123) reported a ≥ 1-point decrease in pain intensity at 30 min (nVNS, 32.2%; sham, 18.5%; P = 0.020), 60 min (nVNS, 38.8%; sham, 24.0%; P = 0.017), and 120 min (nVNS, 46.8%; sham, 26.2%; P = 0.002) after the first attack. Similar significant results were seen when assessing the benefit in all attacks. The proportion of patients who did not require rescue medication was significantly higher with nVNS than with sham for the first attack (nVNS, 59.3%; sham, 41.9%; P = 0.013) and all attacks (nVNS, 52.3%; sham, 37.3%; P = 0.008). When initial pain intensity was mild, the percentage of patients with no pain after treatment was significantly higher with nVNS than with sham at 60 min (all attacks: nVNS, 37.0%; sham, 21.2%; P = 0.025) and 120 min (first attack: nVNS, 50.0%; sham, 25.0%; P = 0.018; all attacks: nVNS, 46.7%; sham, 30.1%; P = 0.037). CONCLUSIONS: This post hoc analysis demonstrated that acute nVNS treatment quickly and consistently reduced pain intensity while decreasing rescue medication use. These clinical benefits provide guidance in the optimal use of nVNS in everyday practice, which can potentially reduce use of acute pharmacologic medications and their associated adverse events. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02686034 .


Assuntos
Transtornos de Enxaqueca/diagnóstico , Transtornos de Enxaqueca/terapia , Autocuidado/instrumentação , Autocuidado/métodos , Estimulação do Nervo Vago/instrumentação , Estimulação do Nervo Vago/métodos , Doença Aguda , Adulto , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento
18.
Epilepsy Behav ; 88S: 33-38, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30241957

RESUMO

For drug-resistant epilepsy, nonpharmacologic treatments should be considered early rather than late. Of the nondrug treatments, only resective surgery can be curative. Neurostimulation is palliative, i.e., not expected to achieve a seizure-free outcome. While resective surgery is the goal, other options are necessary because the majority of patients with drug-resistant epilepsy are not surgical candidates, and others have seizures that fail to improve with surgery or have only partial improvement but not seizure freedom. Neurostimulation modalities include vagus nerve stimulation (VNS), responsive neurostimulation (RNS), and deep brain stimulation (DBS), each with its own advantages, disadvantages, and side effects. In most scenarios, determined by noninvasive evaluation, especially EEG and MRI, several strategies are reasonable. For focal epilepsies, the choices are between resective surgery, with or without intracranial EEG, and all three modalities of neurostimulation. In situations where resective surgery is likely to result in seizure freedom, such as mesiotemporal lobe epilepsy or lesional focal epilepsy, resection (standard, laser, or radiofrequency) is preferred. For difficult cases like extratemporal nonlesional epilepsies, neurostimulation offers a less invasive option than resective surgery. For generalized and multifocal epilepsies, VNS is an option, RNS is not, and DBS has only limited evidence. "This article is part of the Supplement issue Neurostimulation for Epilepsy."


Assuntos
Algoritmos , Estimulação Encefálica Profunda/métodos , Epilepsia Resistente a Medicamentos/terapia , Neuroestimuladores Implantáveis , Estimulação do Nervo Vago/métodos , Estimulação Encefálica Profunda/instrumentação , Epilepsia Resistente a Medicamentos/diagnóstico por imagem , Eletrocorticografia/instrumentação , Eletrocorticografia/métodos , Humanos , Imagem por Ressonância Magnética/métodos , Convulsões/diagnóstico , Convulsões/prevenção & controle , Resultado do Tratamento , Estimulação do Nervo Vago/instrumentação
19.
Expert Rev Med Devices ; 15(8): 527-539, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-30071175

RESUMO

INTRODUCTION: Vagus nerve stimulation (VNS) has become a valuable treatment option for refractory epilepsy and depression. To improve clinical efficacy and minimize side effects, novel device technology for VNS is under development and investigation. AREAS COVERED: For epilepsy, the AspireSR®, and SenTiva™ VNS therapy systems are the two most recently developed VNS devices. These novel devices have implemented a closed-loop approach and contain a cardiac based seizure detection algorithm. The mechanism of action of VNS remains to be further elucidated, but as preclinical research reveals VNS induced effects on brain plasticity, the autonomic nervous system and the inflammatory response, the indications of VNS are expanding. VNS devices are currently being investigated for stroke rehabilitation, treatment of chronic heart failure and rheumatoid arthritis. Recently devices to noninvasively affect vagus nerve functioning have been developed, with the aim of achieving similar effects without the drawbacks of a surgical procedure and continuous stimulation. EXPERT COMMENTARY: Several animal and human trials have shown promising results with minimal adverse events. However, further research needs to be conducted to validate the use of these devices and decide on optimal stimulation parameters.


Assuntos
Estimulação do Nervo Vago/instrumentação , Animais , Aprovação de Equipamentos , Humanos , Reabilitação do Acidente Vascular Cerebral , Resultado do Tratamento , Nervo Vago/fisiopatologia
20.
Psychiatr Clin North Am ; 41(3): 409-418, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30098654

RESUMO

Vagus nerve stimulation (VNS) has been studied for its effect on treatment-resistant depression. Open-label studies have shown a significant positive effect in an especially treatment-resistant depressive population. Insurance company support for VNS has been limited but may be reviewed given recent positive open-label data. Coming developments in novel external ways to stimulate the vagus nerve may revive interest in this area. This article reviews the clinical development of VNS starting with the first recognition of its potential for treating depression, parses the results of several large clinical trials, and suggests a future path for optimal clinical development and use.


Assuntos
Ensaios Clínicos como Assunto , Transtorno Depressivo Maior/terapia , Transtorno Depressivo Resistente a Tratamento/terapia , Estimulação do Nervo Vago/métodos , Humanos , Estimulação do Nervo Vago/efeitos adversos , Estimulação do Nervo Vago/instrumentação
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