Clinical usability study of a home-based self-administration transcranial direct current stimulation for primary dysmenorrhea: A randomized controlled trial.

This study tested the usability of a home-based self-administration transcranial direct current stimulation (tDCS) device designed specifically for women's health needs. This is a single center triple blinded clinical usability study for a new wireless, Bluetooth-controlled wearable tDCS device for women's health. The study aims to evaluate the usability and effective blinding of a home-based tDCS system. A total of forty-nine women of reproductive age were randomly allocated (1:1) to receive one session of active tDCS (n = 24) or sham tDCS (n = 25) over the motor and dorsolateral prefrontal cortex. Each participant self-administered one 20-minute session without supervision following guidance on a software application alone. The System Usability Scale (SUS) and the Patient Global Impression of Change (PGIC) were used to evaluate the usability of the system. Regardless of sham or active conditions, all users found the system easy to use without the support of researchers. Usability scores were considered to be "excellent" in both groups and no significant difference was found between sham and active groups showing effective blinding of the device (Active group: 93.7 (83.1-97.5); Sham group 90 (86.2-95) p = 0.79) and PGIC (Active group: 2 (1-2.75); Sham group 2 (1-2) p = 0.99) using an unpaired t-test or non-parametric statistical tests accordingly. The new Bluetooth-controlled wearable tDCS device is easy, safe to use and completely controlled by a smartphone app. This device is focused on women's health and will be tested as an alternative treatment for chronic pelvic pain and mood disturbance associated with menstrual cycles in further research.

The Flow brain stimulation headset for the treatment of depression: overview of its safety, efficacy and portable design.

INTRODUCTION: Major depressive disorder (MDD) is a prevalent and debilitating condition. First-line treatments include antidepressants and cognitive-behavioral psychotherapy (CBT). However, several patients present treatment-resistance and/or adverse effects. Transcranial direct current stimulation (tDCS), a noninvasive neuromodulation technique, is an effective alternative for MDD. AREAS COVERED: We hereby review a portable tDCS device designed to be combined with a cognitive-behavioral intervention. This home-use device was developed by Flow Neuroscience™ and was recently approved in the UK and European Union. We discuss present evidence on tDCS efficacy and safety, both as a monotherapy and as a combined treatment. Moreover, we show a computer modeling tDCS procedure based on Flow parameters and montage. EXPERT OPINION: Electric field simulations revealed that Flow's tDCS device targets prefrontal cortical areas involved in MDD pathophysiology. In addition, the safety and efficacy profile revealed from prior tDCS studies support its use in depression. Finally, combining tDCS with cognitive-behavioral interventions might further enhance overall efficacy, although this aspect should be investigated in upcoming randomized, placebo-controlled trials.

Safety of transcranial direct current stimulation in a patient with deep brain stimulation electrodes.

BACKGROUND: Transcranial direct current stimulation (tDCS) has been investigated in movement disorders, making it a therapeutic alternative in clinical settings. However, there is still no consensus on the most appropriate treatment protocols in most cases, and the presence of deep brain stimulation (DBS) electrodes has been regarded as a contraindication to the procedure. We recently studied the effects of cerebellar tDCS on a female patient already undergoing subthalamic nucleus deep brain stimulation (STN-DBS) for generalized dystonia. She also presented with chronic pain and depression. With STN-DBS, there was improvement of dystonia, and botulinum toxin significantly reduced pain. However, depressive symptoms were worse after STN-DBS surgery. METHODS: Neuromodulation with 2 mA anodal cerebellar tDCS was initiated, targeting both hemispheres in each daily 30 minute session: 15 minutes of left cerebellar stimulation followed by 15 minutes of right cerebellar stimulation. The DBS electrodes were in place and functional, but the current was turned off during tDCS. RESULTS: Although our goal was to improve dystonic movements, after 10 tDCS sessions there was also improvement in mood with normalization of Beck Depression Inventory scores. There were no complications in spite of the implanted STN-DBS leads. CONCLUSION: Our results indicate that tDCS is safe in patients with DBS electrodes and may be an effective add-on neuromodulatory tool in the treatment of potential DBS partial efficacy in patients with movement disorders.

Safety of transcranial direct current stimulation in a patient with deep brain stimulation electrodes / Segurança da estimulação transcraniana por corrente contínua em uma paciente com implante de eletrodos de estimulação cerebral profunda

ABSTRACT Background: Transcranial direct current stimulation (tDCS) has been investigated in movement disorders, making it a therapeutic alternative in clinical settings. However, there is still no consensus on the most appropriate treatment protocols in most cases, and the presence of deep brain stimulation (DBS) electrodes has been regarded as a contraindication to the procedure. We recently studied the effects of cerebellar tDCS on a female patient already undergoing subthalamic nucleus deep brain stimulation (STN-DBS) for generalized dystonia. She also presented with chronic pain and depression. With STN-DBS, there was improvement of dystonia, and botulinum toxin significantly reduced pain. However, depressive symptoms were worse after STN-DBS surgery. Methods: Neuromodulation with 2 mA anodal cerebellar tDCS was initiated, targeting both hemispheres in each daily 30 minute session: 15 minutes of left cerebellar stimulation followed by 15 minutes of right cerebellar stimulation. The DBS electrodes were in place and functional, but the current was turned off during tDCS. Results: Although our goal was to improve dystonic movements, after 10 tDCS sessions there was also improvement in mood with normalization of Beck Depression Inventory scores. There were no complications in spite of the implanted STN-DBS leads. Conclusion: Our results indicate that tDCS is safe in patients with DBS electrodes and may be an effective add-on neuromodulatory tool in the treatment of potential DBS partial efficacy in patients with movement disorders.

RESUMO Descrição: A estimulação transcraniana por corrente contínua (ETCC) tem sido investigada nos distúrbios de movimento, tornando-a uma alternativa terapêutica no contexto clínico. Contudo, não há consenso quanto aos protocolos mais apropriados na maioria dos casos e a presença de eletrodos de estimulação cerebral profunda (ECP) é geralmente considerada uma contraindicação. Recentemente, estudamos os efeitos da ETCC cerebelar em uma paciente do sexo feminino com implante de eletrodos de estimulação cerebral profunda (ECP) para distonia generalizada. Ela também apresentava dor crônica e depressão. A ETCC foi realizada dois anos após o implante de eletrodos de ECP. Com a ECP houve melhora da distonia e a toxina botulínica reduziu a dor. Contudo, os sintomas depressivos pioraram após a cirurgia de ECP. Métodos: Foi proposta ETCC cerebelar anódica de 2mA, sobre os dois hemisférios em cada sessão de 30min: 15 min de ETCC cerebelar esquerda seguida de 15min de ETCC cerebelar direita. Resultados: Embora o nosso objetivo tenha sido melhorar os movimentos distônicos, após 10 sessões de ETCC houve melhora também do humor da paciente. Não houve nenhuma complicação, apesar da presença de eletrodos de ECP. Conclusão: Nossos resultados apontam para a segurança da tDCS e sua aplicação potencial e efetiva como ferramenta neuromodulatória adicional no tratamento de possíveis sintomas persistentes após a ECP em pacientes com distúrbios de movimento.

Transcranial direct current stimulation (tDCS) for preventing major depressive disorder relapse: Results of a 6-month follow-up.

BACKGROUND: The efficacy of transcranial direct current stimulation (tDCS) as a continuation therapy for the maintenance phase of the depressive episode is low and insufficiently investigated in literature. We investigated whether it could be enhanced by using a more intensive treatment regimen compared to previous reports. METHODS: Twenty-four patients (16 with unipolar depression and eight with bipolar depression) who presented acute tDCS response (≥50% depression improvement in the Hamilton Depression Rating Scale [HDRS]) after receiving 15 tDCS sessions were followed for up to 6 months or until relapse, defined as clinical worsening and/or HDRS > 15. Sessions were performed twice a week (maximum of 48 sessions) over 24 weeks. The anode and the cathode were positioned over the left and right dorsolateral prefrontal cortex (2 mA current, 30 min sessions were delivered). We performed Kaplan-Meier survival analysis and Cox proportional hazards ratios to evaluate predictors of relapse. RESULTS: Out of 24 patients, 18 completed the follow-up period. tDCS treatment was well tolerated. The mean survival duration was 17.5 weeks (122 days). The survival rate at the end of follow-up was 73.5% (95% confidence interval, 50-87). A trend (P = 0.09) was observed for lower relapse rates in nontreatment- vs. antidepressant treatment-resistant patients (7.7% vs. 45.5%, respectively). No differences in efficacy between unipolar and bipolar depression were observed. CONCLUSION: An intensive tDCS treatment regimen consisting of sessions twice a week achieved relatively low relapse rates after a 6-month follow up of tDCS responders, particularly for nontreatment-resistant patients.

Efeitos da estimulação transcraniana por corrente contínua sobre a dor e capacidade funcional em mulheres acometidas por chukungunya: um ensaio clínico randomizado / Effects of transcranial direct current stimulation on pain and functional capacity in women affected by chukungunya: a randomized clinical trial

A Chikungunya é uma afecção que tem atingido milhares de brasileiros, com números alarmantes de casos graves e incapacitantes em todo território nacional. É transmitida pelo mosquito Aedes Aegypti e causa febre de início agudo, dores articulares e musculares. A persistência dos sintomas de dor articular contínua e incapacitante tem sido considerada uma forte preocupação para a saúde pública, em virtude do comprometimento funcional e laboral que tem causado a população. Ainda não existe um tratamento específico para os casos de dor crônica causada pela Chikungunya e os mecanismos responsáveis pela cronificação das dores podem estar envolvidos com mecanismos centrais de controle da dor. Técnicas de neuromodulação poderiam atuar sobre esses efeitos e dentre elas existe a Estimulação Transcraniana por Corrente Continua (ETCC), que é uma técnica de aplicação de correntes de baixa intensidade sobre o escalpo com o intuito de modular a excitabilidade de áreas corticais envolvidas no processamento da dor crônica e tem se mostrado eficiente no tratamento desses casos. O objetivo desse estudo foi analisar o efeito da ETCC sobre as dores crônicas e capacidade funcional em mulheres acometidas por Chikungunya. Realizouse um estudo do tipo ensaio clínico randomizado, composto por mulheres com idade entre 28 e 70 anos, divididas em dois grupos experimental (ETCC) e placebo (SHAM). Foram avaliadas as características sociodemográficas e clínicas dos participantes, bem como o nível de capacidade funcional e sintomatologia dolorosa antes e após serem submetidos a seis sessões de ETCC em dias não consecutivos. Participaram do estudo 59 mulheres, com média de idade de 52,85 ±10,76 anos e o tempo de acometimento da doença apresentou uma média de 21,54 ±3,53 meses. Pode-se concluir com esse estudo que a ETCC foi efetiva para a redução das dores crônicas provenientes de indivíduos acometidos por Chikungunya (p< 0,007) a curto prazo, porém não foi capaz de alterar a capacidade funcional e interferência das dores no seu dia-a-dia. Sugere-se que outros estudos dessa natureza possam contemplar um tempo maior de acompanhamento do comportamento das dores crônicas nesse público e associar a ETCC a outros recursos terapêuticos para observar seus efeitos isolados e combinados (AU).

Chikungunya is a condition that has reached thousands of Brazilians, with alarming numbers of serious and incapacitating cases throughout the country. It is transmitted by the Aedes Aegypti mosquito and causes acute onset fever, joint and muscle pain. The persistence of symptoms of continuous and disabling joint pain has been considered a strong concern for public health, due to the functional and labor compromise that has caused the population. There is still no specific treatment for cases of chronic pain caused by Chikungunya and the mechanisms responsible for chronic pain can be involved with central mechanisms of pain control. Neuromodulation techniques could act on these effects and among them there is Transcranial Direct Current Stimulation (TDCS), which is a technique of applying currents of low intensity on the scalp in order to modulate the excitability of cortical areas involved in the processing of chronic pain and has been shown to be efficient in the treatment of these cases. The objective of this study was to analyze the effect of TDCS on chronic pain and functional capacity in women affected by Chikungunya. A randomized clinical trial, consisting of women aged 28 to 70 years, divided into two experimental groups (GTDCS) and placebo (GSHAM) was performed. The sociodemographic and clinical characteristics of the participants were evaluated, as well as the level of functional capacity and pain symptomatology before and after being submitted to six sessions of TDCS on non-consecutive days. A total of 59 women participated in the study, with a mean age of 52.85 ± 10.76 years and the time of disease involvement presented a mean of 21.54 ± 3.53 months. It can be concluded from this study that the ETCC was effective for the reduction of chronic pain from individuals affected by Chikungunya (p <0.007) in the short term, but it was not able to change the functional capacity and interference of the pains in their day- to-day. It is suggested that other studies of this nature may contemplate a greater time of monitoring the behavior of chronic pain in this public and associate CTEF with other therapeutic resources to observe its isolated and combined effects (AU).

Primum non nocere or primum facere meliorem? Hacking the brain in the 21st century / Primum non nocere ou primum facem meliorem? O cérebro pirateado do século 21

Abstract Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that modulates cortical excitability. It is devoid of serious adverse events and exerts variable effects on cognition, with several research findings suggesting that it can improve memory, verbal and mathematical skills. Because tDCS devices are low-cost, portable and relatively easy to assemble, they have become available outside of the medical setting and used for non-medical ("cosmetic") purposes by laypersons. In this sense, tDCS has become a popular technique aiming to improve cognition and the achievement of a better performance not only at work, but also in other fields such as sports, leisure activities (video games) and even the military. In spite of these unforeseen developments, there has been a general paralysis of the medical and regulatory agencies to develop guidelines for the use of tDCS for cosmetic purposes. Several challenges are present, most importantly, how to restrict tDCS use outside of the medical setting in face of variable and sometimes conflicting results from scientific research. This article aims to describe the popular use of tDCS, in light of the pillars of neuroethics, a branch of bioethics relative to brain research. Between two possible but extreme solutions - total release or total restriction of tDCS - it is paramount to develop a spectrum of alternatives, which may vary over time and in different cultural backgrounds.

Resumo A estimulação transcraniana por corrente contínua (ETCC) é uma técnica não invasiva de estimulação cerebral que modula a excitabilidade cortical. A ETCC é desprovida de efeitos adversos graves e exerce efeitos variáveis sobre a cognição, com vários achados de pesquisa sugerindo que a técnica pode promover melhora nas habilidades mnêmica, verbal e matemática. Devido ao seu baixo custo, portabilidade e facilidade de montagem, os aparelhos de ETCC tornaram-se disponíveis fora do contexto médico, sendo usados para fins não médicos ("cosméticos") por indivíduos leigos. Nesse sentido, a ETCC tornou-se um procedimento popular para aprimoramento da cognição e a realização de melhor desempenho não somente no ambiente de trabalho, mas também em campos tais como o esporte, atividades de lazer ( video games ) e até no meio militar. Apesar desses acontecimentos imprevisíveis, há uma certa morosidade das agências médicas e regulatórias em desenvolver diretrizes para o uso de ETCC para fins cosméticos. Há muitos desafios presentes, principalmente, como restringir o uso da ETCC fora do contexto médico em face de resultados variáveis, e muitas vezes conflitantes, da pesquisa científica sobre o tema. Este artigo tem como objetivo descrever o uso popular da ETCC sob a luz da neuroética, um ramo da bioética que se dedica ao estudo do cérebro. Entre duas situações possíveis, mas extremas - liberação ou restrição totais da ETCC -, é primordial o desenvolvimento de um espectro de alternativas, que podem variar ao longo do tempo e depender de diversos contextos culturais.

Primum non nocere or primum facere meliorem? Hacking the brain in the 21st century.

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that modulates cortical excitability. It is devoid of serious adverse events and exerts variable effects on cognition, with several research findings suggesting that it can improve memory, verbal and mathematical skills. Because tDCS devices are low-cost, portable and relatively easy to assemble, they have become available outside of the medical setting and used for non-medical ("cosmetic") purposes by laypersons. In this sense, tDCS has become a popular technique aiming to improve cognition and the achievement of a better performance not only at work, but also in other fields such as sports, leisure activities (video games) and even the military. In spite of these unforeseen developments, there has been a general paralysis of the medical and regulatory agencies to develop guidelines for the use of tDCS for cosmetic purposes. Several challenges are present, most importantly, how to restrict tDCS use outside of the medical setting in face of variable and sometimes conflicting results from scientific research. This article aims to describe the popular use of tDCS, in light of the pillars of neuroethics, a branch of bioethics relative to brain research. Between two possible but extreme solutions - total release or total restriction of tDCS - it is paramount to develop a spectrum of alternatives, which may vary over time and in different cultural backgrounds.

Safety of the Transcranial Focal Electrical Stimulation via Tripolar Concentric Ring Electrodes for Hippocampal CA3 Subregion Neurons in Rats.

Epilepsy is a neurological disorder that affects approximately one percent of the world population. Noninvasive electrical brain stimulation via tripolar concentric ring electrodes has been proposed as an alternative/complementary therapy for seizure control. Previous results suggest its efficacy attenuating acute seizures in penicillin, pilocarpine-induced status epilepticus, and pentylenetetrazole-induced rat seizure models and its safety for the rat scalp, cortical integrity, and memory formation. In this study, neuronal counting was used to assess possible tissue damage in rats (n = 36) due to the single dose or five doses (given every 24 hours) of stimulation on hippocampal CA3 subregion neurons 24 hours, one week, and one month after the last stimulation dose. Full factorial analysis of variance showed no statistically significant difference in the number of neurons between control and stimulation-treated animals (p = 0.71). Moreover, it showed no statistically significant differences due to the number of stimulation doses (p = 0.71) nor due to the delay after the last stimulation dose (p = 0.96). Obtained results suggest that stimulation at current parameters (50 mA, 200 µs, 300 Hz, biphasic, charge-balanced pulses for 2 minutes) does not induce neuronal damage in the hippocampal CA3 subregion of the brain.

Transcranial direct current stimulation in obsessive-compulsive disorder: emerging clinical evidence and considerations for optimal montage of electrodes.

BACKGROUND: Neuromodulation techniques for obsessive-compulsive disorder (OCD) treatment have expanded with greater understanding of the brain circuits involved. Transcranial direct current stimulation (tDCS) might be a potential new treatment for OCD, although the optimal montage is unclear. OBJECTIVE: To perform a systematic review on meta-analyses of repetitive transcranianal magnetic stimulation (rTMS) and deep brain stimulation (DBS) trials for OCD, aiming to identify brain stimulation targets for future tDCS trials and to support the empirical evidence with computer head modeling analysis. METHODS: Systematic reviews of rTMS and DBS trials on OCD in Pubmed/MEDLINE were searched. For the tDCS computational analysis, we employed head models with the goal of optimally targeting current delivery to structures of interest. RESULTS: Only three references matched our eligibility criteria. We simulated four different electrodes montages and analyzed current direction and intensity. CONCLUSION: Although DBS, rTMS and tDCS are not directly comparable and our theoretical model, based on DBS and rTMS targets, needs empirical validation, we found that the tDCS montage with the cathode over the pre-supplementary motor area and extra-cephalic anode seems to activate most of the areas related to OCD.

Ultrasound therapy and transcutaneous electrical neuromuscular stimulation for management ofpost-mastectomy upper limb lymphedema / Terapia de ultrassom e estimulação elétrica transcutânea neuromuscular para a tratamento do linfedema de membro superior pós-mastectomia

Objetivo: Avaliar o efeito da estimulação elétrica transcutânea ou terapia de ultra-som no tratamento de pós-mastectomia linfedema do membro superior. Método: revisão sistemática da literatura foi realizada 1980-2012 do MedLine, Cochrane Library, LILACS e SciELO. Os termos utilizados na pesquisa foram (neoplasia de mama ou câncer de mama ou de linfedema) e (hipertermia, induzido ou diatermia ou terapia de ultra-som ou ultra-som ou a estimulação elétrica nervosa transcutânea ou dezenas). As seleções dos estudos eram de pacientes mulheres com linfedema pós-mastectomia membro superior que foram submetidos a diatermia por terapia de ultra-som e estimulação elétrica nervosa transcutânea. Só randomizado (RCT) e projetos quase randomizados do estudo foram incluídos (ambos estreita e Broad Therapy). Somente estudos publicados no formato de artigo completo foram incluídos. Depois de analisar os 2.158 resumos resultantes da pesquisa, foram selecionados apenas dois artigos. Dois pesquisadores analisaram os dois artigos, usando o Van Tulder e JADAD escalas para avaliação da qualidade. Resultados: Ambos os trabalhos avaliaram o uso da terapia de ultra-som e estimulação elétrica para o tratamento do linfedema pós-mastectomia. Um total de 132 indivíduos foram incluídos em ambos os estudos, e pouca melhora foi observada em redução ou a qualidade de vida da dor. Somente o estudo usando a terapia de ultra-som identificada uma pequena redução nos sintomas de linfedema. No entanto evidências que suportam a aplicação deste método está faltando. Conclusão: Mais estudos são necessários para avaliar o uso da terapia de ultra-som ou eletroterapia para o tratamento de linfedema pós-mastectomia e para avaliar o efeito potencial dessas terapias no desenvolvimento posterior da doença metastática.

Objective: This article aims to assess the effect of transcutaneous electrical stimulation or ultrasound therapy in the treatment of post-mastectomy upper limb lymphedema. Method: A systematic literature review was performed from 1980 to 2012 from the MedLine, Cochrane Library, LILACS and SciELO databases. The terms used in the search were (breast neoplasm OR breast cancer OR lymphedema) and (hyperthermia, induced OR diathermy OR ultrasonic therapy OR ultrasound OR transcutaneous electrical nerve stimulation OR TENS). The selections of the studies concerned female patients with post-mastectomy upper limb lymphedema who underwent diathermy by ultrasound therapy and transcutaneous electric nerve stimulation. Only randomized (RCT) and quasi-randomized study designs were included (both Narrow and Broad Therapy). Only studies published in the full paper format were included. After reviewing the 2,158 abstracts resulting from the search, only two papers were selected. Two researchers analyzed the two articles, using the Van Tulder and JADAD scales for quality assessment. Results: Both papers evaluated the use of ultrasound therapy and electric stimulation for treatment of post-mastectomy lymphedema. A total of 132 subjects were included in these two studies, and little improvement was observed in pain reduction or quality of life. Only the study using ultrasound therapy identified a small reduction in lymphedema symptoms; however, evidence supporting the application of this method is lacking. Conclusion: Further studies are needed to evaluate the use of ultrasound therapy or electrotherapy for treatment of post-mastectomy lymphedema and to evaluate the potential effect of these therapies on later development of metastatic disease.