A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials.

BACKGROUND: Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation investigated as a treatment for several neuropsychiatric disorders. Notwithstanding tDCS-induced adverse events (AEs) are considered to be low and transient, systematic review analyses on safety and tolerability of tDCS derive mostly from single-session studies. OBJECTIVE: To investigate the tolerability (rate of AEs) and acceptability (rate of dropouts) of tDCS. METHODS: Systematic review and meta-analysis of tDCS randomized, sham-controlled trials in healthy or neuropsychiatric adult samples from the first date available to March 9, 2016. We only included parallel studies performing at least 5 tDCS sessions. An adapted version of CONSORT guidelines for reporting harms outcomes was used to evaluate AE reporting. RESULTS: Sixty-four studies (2262 participants) were included. They had a low risk of publication bias and methodological bias for the items assessed. Dropout rates in active and sham tDCS groups were, respectively, 6% and 7.2% (OR = 0.82 [0.59-1.14]). However, almost half of studies reported no dropouts and only 23.4% reported its reasons; when reported, the most frequent reasons were AEs and protocol violation. A tolerability meta-analysis was not performed, as most studies did not report AEs. The quality of AEs reporting was also limited, particularly in smaller studies and stroke studies. CONCLUSIONS: Although overall dropout rate was low and similar in active and sham groups, studies did not adequately describe AEs. An updated questionnaire and guidelines for assessment of AEs in tDCS trials are proposed in order to standardize the reporting of AE in the field.

Transcranial direct current stimulation in psychiatric disorders.

The interest in non-invasive brain stimulation techniques is increasing in recent years. Among these techniques, transcranial direct current stimulation (tDCS) has been the subject of great interest among researchers because of its easiness to use, low cost, benign profile of side effects and encouraging results of research in the field. This interest has generated several studies and randomized clinical trials, particularly in psychiatry. In this review, we provide a summary of the development of the technique and its mechanism of action as well as a review of the methodological aspects of randomized clinical trials in psychiatry, including studies in affective disorders, schizophrenia, obsessive compulsive disorder, child psychiatry and substance use disorder. Finally, we provide an overview of tDCS use in cognitive enhancement as well as a discussion regarding its clinical use and regulatory and ethical issues. Although many promising results regarding tDCS efficacy were described, the total number of studies is still low, highlighting the need of further studies aiming to replicate these findings in larger samples as to provide a definite picture regarding tDCS efficacy in psychiatry.

Reducing transcranial direct current stimulation-induced erythema with skin pretreatment: considerations for sham-controlled clinical trials.

OBJECTIVES: Transcranial direct current stimulation (tDCS)-induced erythema (skin reddening) has been described as an adverse effect that can harm blinding integrity in sham-controlled designs. To tackle this issue, we investigated whether the use of topical pretreatments could decrease erythema and other adverse effects associated with tDCS. MATERIALS AND METHODS: Thirty healthy volunteers were recruited, and four interventions were applied 30 min prior to tDCS in a Latin square design: placebo, ketoprofen 2%, hydroxyzine 1%, and lidocaine 5%. TDCS was applied for 30 min (2 mA, anode and cathode over F3 and F4, respectively) in two active sessions with a minimum 1-week interval. The Draize erythema scoring system scale was used to assess erythema intensity; a tDCS questionnaire was used to assess other adverse effects (e.g., tingling, itching, burning sensation, and pain). RESULTS: We found that ketoprofen (but not hydroxyzine or lidocaine) significantly attenuated tDCS-induced erythema regarding intensity and duration, with a medium effect compared with placebo. Erythema was overall mild, short-lived (lasting 18-24 min after tDCS ending), and more intense under the anode. Subjects with darker skin color also tended to present less intense tDCS-induced erythema. The prevalence of other adverse effects was low and did not differ between dermatological groups. CONCLUSIONS: Ketoprofen 2% topical pretreatment might be an interesting strategy to reduce tDCS-induced erythema and might be useful for blinding improvement in further sham-controlled tDCS trials.

Socio-demographic and clinical characteristics of pregnant and puerperal crack-cocaine using women: preliminary data

BACKGROUND The literature provides several studies on the effects of cocaine when exposed to the fetus. However, the majority of these data comes from animal models. OBJECTIVE The objective of this study is to present socio-demographic and clinical data in crack-cocaine using pregnant women and their babies, as compared to non-users. METHODS Cross-sectional study, comprised by 56 dyads of crack-cocaine using mothers-babies and 89 control dyads. In addition to the socio-demographic data and the babies’ information, data collection was based on ABIPEMI for socioeconomic level, WAIS for IQ, MINI for psychopathology and ASSIST for drug use. RESULTS Most crack users, in comparison to non-users, did not have a partner (10.52% vs 4.4%, P = 0.001) and presented lower IQ (78.15, +/-8.07 vs 84.27 +/- 9.87; P = 0.002). The prevalence of antisocial personality disorder and suicide risk in users was higher than in non-users (24.44% vs none, P < 0.001; 28.26% vs 10.46% P = 0.01). Most of the users did not participate in prenatal care (75%). The babies that the crack-cocaine using mothers gave birth to weighed significantly less than the controls (2.858 g vs 3.240 g, P = 0.002). DISCUSSION Users had a higher degree of psychopathology and lower attendance in prenatal care. There was an overlap of adverse factors, both for exposed mothers and babies. The sum of these vulnerabilities could result in significant harm to the developing infant. .

Psychometric properties of Social Rhythm Metric in regular shift employees.

OBJECTIVE: To analyze the psychometric properties of Brazilian version of Social Rhythm Metric-17 and to present the score algorithm in regular shift employees. METHOD: This is a cross-sectional study. The Social Rhythm Metric assess the regularity of daily life associated to changes in biological rhythms. The scale was applied, during nine days, to 145 employees, 27.6 % male and 72.4% female, ages between 18 and 60, mean = 36.1 (sd = 9.87). Mean values were compared using the Student's t-test for independent samples and ANOVA. Factor analysis was performed using principal component analysis; the reliability analysis, through Spearman's correlation. RESULTS: The Student t test didn't reveal any significant difference between sex in IRA (t = 0.60; p = 0.55) or ETA (t = 0.67; p = 0.95). The factor analysis showed three components, the first was associated to survival related activities; the second, related to pleasure and work and the third was related to no essential survive activities. DISCUSSION: This version of the Social Rhythm Metric-17 instrument allows to assess an important human zeitgeber, contributing for other studies which can to evaluate the determinant role of social rhythm. CONCLUSION: The Brazilian version of social rhythm metric 17 presents validity of content and good test-retest reliability.

Psychometric properties of Social Rhythm Metric in regular shift employees / Propriedades psicométricas da Escala de Ritmo Social em trabalhadores de turno regular

OBJECTIVE: To analyze the psychometric properties of Brazilian version of Social Rhythm Metric-17 and to present the score algorithm in regular shift employees. METHOD: This is a cross-sectional study. The Social Rhythm Metric assess the regularity of daily life associated to changes in biological rhythms. The scale was applied, during nine days, to 145 employees, 27.6 percent male and 72.4 percent female, ages between 18 and 60, mean = 36.1 (sd = 9.87). Mean values were compared using the Student's t-test for independent samples and ANOVA. Factor analysis was performed using principal component analysis; the reliability analysis, through Spearman's correlation. RESULTS: The Student t test didn't reveal any significant difference between sex in IRA (t = 0.60; p = 0.55) or ETA (t = 0.67; p = 0.95). The factor analysis showed three components, the first was associated to survival related activities; the second, related to pleasure and work and the third was related to no essential survive activities. DISCUSSION: This version of the Social Rhythm Metric-17 instrument allows to assess an important human zeitgeber, contributing for other studies which can to evaluate the determinant role of social rhythm. CONCLUSION: The Brazilian version of social rhythm metric 17 presents validity of content and good test-retest reliability.

OBJETIVO: Analisar as propriedades psicométricas da Escala de Ritmo Social e apresentar o algoritmo para cálculo dos escores em trabalhadores de turno regular. MÉTODO: Este estudo tem delineamento transversal. A escala Escala de Ritmo Social, que afere a regularidade de atividades diárias, foi aplicada durante nove dias, em 145 trabalhadores de turno regular, ambos os sexos, 27,6 por cento sexo masculino e 72,4 por cento sexo feminino, com idades entre 18 e 60 anos, média = 36,1 (sd = 9,87). A análise da diferença entre as médias foi realizada por meio do teste t de Student para amostras independentes e ANOVA. A análise fatorial foi realizada por meio de análise de componentes principais; a confiabilidade foi analisada através da correlação de Spearman. RESULTADOS: O teste t de Student não revelou diferença significativa entre os sexos para o Índice de Regularidade de Atividades (t = 0,60; p = 0,55) e para o Escore do Total de Atividades (t = 0,67; p = 0,95). Os escores apresentaram uma distribuição gaussiana na amostra estudada. A análise fatorial mostrou que a escala se agrupa em três componentes, o primeiro deles composto pelas atividades mais impositivas e imprescindíveis para a sobrevivência; o segundo relacionado a trabalho e lazer, e o terceiro o das atividades às quais as pessoas podem frequentemente dispensar sem prejuízo de sua sobrevivência. DISCUSSÃO: Esta versão permite aferição de um importante zeitgeber em humanos, contribuindo para próximos estudos nos quais possa ser avaliado o papel determinante do ritmo social. CONCLUSÃO: A Escala de Ritmo Social apresenta validade de conteúdo e boa fidedignidade teste-reteste.