Yes / Introduction: Skin ageing involves senescent fibroblast accumulation, disturbance in extracellular matrix (ECM) homeostasis, and decreased collagen synthesis. Objective: to assess a cell therapy product for aged skin (RCS-01; verum) consisting of ~25 × 106 cultured, autologous cells derived from anagen hair follicle non-bulbar dermal sheath (NBDS). Methods: For each subject in the verum group, 4 areas of buttock skin were injected intradermally 1 or 3 times at monthly intervals with RCS-01, cryomedium, or needle penetration without injection; in the placebo group RCS-01 was replaced by cryomedium. The primary endpoint was assessment of local adverse event profiles. As secondary endpoints, expression of genes related to ECM homeostasis was assessed in biopsies from randomly selected volunteers in the RCS-01 group taken 4 weeks after the last injection. ­Results: Injections were well tolerated with no severe adverse events reported 1 year after the first injection. When compared with placebo-treated skin, a single treatment with RCS-01 resulted in a significant upregulation of TGFβ1, CTGF, COL1A1, COL1A2, COL3A1, and lumican mRNA expression. Limitations: The cohort size was insufficient for dose ­ranging evaluation and subgroup analyses of efficacy. Conclusions: RCS-01 therapy is well tolerated and associated with a gene expression response consistent with an improvement of ECM homeostasis. / Replicel Life Sciences Inc, Vancouver, Canada.

Yes / Background: The aim of this study was to investigate whether the prior consumption of 200mg of pure caffeine affected neuropsychological test scores in a group of elderly participants aged over 60 years. Method: Using a double blind placebo vs. caffeine design, participants were randomly assigned to receive 200mg of caffeine or placebo. A neuropsychological assessment testing the domains of general cognitive function, processing speed, semantic memory, episodic memory, executive function, working memory and short-term memory was carried out. Results: Significant interaction effects between age, caffeine and scores of executive function and processing speed were found; participants who had received caffeine showed a decline in performance with increasing age. This effect was not seen for participants who received placebo. Conclusion: The results highlight the need to consider and control prior caffeine consumption when scoring neuropsychological assessments in the elderly which is important for accuracy of diagnosis and corresponding normative data.

Le neurofeedback (NF) suscite actuellement un vif intérêt dans la prise en charge du trouble déficitaire de l’attention avec hyperactivité (TDAH) chez l’enfant. Proposée comme méthode alternative à la médication par de nombreux cliniciens, notamment aux États-Unis, le NF est une intervention non-invasive de type électrophysiologique qui repose sur l’apprentissage par conditionnement opérant de l’autorégulation d’ondes cérébrales déviantes. Les études empiriques qui étayent cette pratique font toutefois l’objet de virulentes critiques de la part de spécialistes dans le domaine du TDAH en raison de résultats systématiquement positifs mais non spécifiques, auxquels s’ajoutent de nombreuses lacunes méthodologiques. Les travaux de cette thèse visent à appliquer une méthodologie stricte de type essai clinique contrôlé avec assignation aléatoire afin d’isoler les effets particuliers du NF, en appliquant un protocole d’entraînement propre au déficit primaire sous-tendant le TDAH, soit l’inhibition motrice, dans le but d’évaluer la spécificité de cette intervention. Dans un premier temps, les connaissances relatives à la nosologie du TDAH, à ses principaux traitements, au NF et aux capacités d’inhibition chez l’enfant ayant un TDAH sont présentées (Chapitre 1). Ensuite, les études réalisées dans le cadre de cette thèse sont exposées. Dans l’étude initiale, la spécificité du NF est évaluée sur les capacités d’inhibition grâce à des mesures subjectives, soit des questionnaires de comportements complétés par les parents, ainsi que des mesures objectives, à savoir des tâches neuropsychologiques (Chapitre 2). Afin de préciser davantage les conséquences d’un entraînement à l’autorégulation d’ondes cérébrales, l’étude subséquente s’est intéressée à l’impact neurophysiologiques de l’amélioration des capacités d’inhibition, par le biais d’une étude en potentiels évoqués employant une tâche de performance continue de type Stop-signal (Chapitre 3). Les principaux résultats reflètent un recrutement sous optimal, avec une puissance statistique insuffisante pour réaliser des statistiques quantitatives de groupe. Néanmoins, l’appréciation des données selon une approche d’étude de cas multiples permet de mettre en évidence la présence d’une réponse placebo sur les capacités d’inhibition suite à un entraînement en NF. Finalement, les implications de la taille de l’échantillon, ainsi que les limites et les critiques de ces études sont discutées au Chapitre 4. / In recent years, there has been a lively interest in the use of neurofeedback (NF) as an alternative treatment to pharmacotherapy in pediatric Attention-deficit hyperactivity disorder (ADHD). NF is defined as an operant conditioning procedure whereby an individual learns to self-regulate electrical brain activity. Yet, empirical studies supporting its practice are harshly criticized in the field of ADHD research due to systematic unspecific positive results associated to numerous methodological flaws. Studies presented in this dissertation aim at applying a randomized placebo-controlled clinical trial to the investigation of NF specific effects. In order to further establish treatment specificity, we trained the participants using a NF protocol characteristic to motor-inhibition functioning since it has repeatedly been described as the core deficit in ADHD. The fist part of this thesis comprises a brief review of knowledge concerning ADHD, principal treatments offered for this disorder, NF research in pediatric ADHD and inhibition abilities in these children (Chapter 1). Following are the two studies conducted as part of this dissertation. In the initial study, effects of NF training are investigated on inhibition capacities by means of behavior rating scales and neuropsychological tests (Chapter 2). With the aim of further defining the consequence of training to self-regulate ones brain activity, the subsequent study looks at the neurophysiologic impact of improving inhibition capacities with an event-related potential study using a Stop-signal continuous performance task (Chapter 3). The principal results reveal a non optimal recruitment, with insufficient statistical power, thus precluding quantitative group statistics. Nevertheless, appreciating the data from a multiple case study perspective enables to suggest that a placebo response could be at play following NF training, such as measured by improvements on inhibition capacities. Finally, the implications of such a small sample size, limits and critics of these studies are discussed in Chapter 4.

O jogo patológico é classificado como um transtorno do controle dos impulsos, que envolve a fissura e a impulsividade para jogar, causando prejuízos sociais. Estudos prévios sugeriram que o topiramato poderia ser mais eficaz do que o placebo no tratamento de alguns transtornos relacionados com impulsividade, tais como transtorno de compulsão alimentar periódico, alcoolismo e dependência de cocaína. O principal objetivo deste estudo foi verificar se o topiramato foi superior ao placebo em controlar fissura e reduzir pensamentos e comportamentos relacionados ao jogo. Método: os jogadores patológicos foram aleatoriamente distribuídos em um de dois grupos: o que recebeu topiramato (n=15) e o que recebeu placebo (n=15) por 12 semanas. Durante o estudo, todos os pacientes participaram de quatro sessões psicoeducacionais, baseadas no programa de 12 passos dos jogadores anônimos. A principal variável de desfecho foi a escala G-SAS. As demais variáveis de desfecho foram consideradas secuindárias, sendo as escalas/entrevista: Escala Yale Brown de obsessão e compulsão adaptada para jogo patológico (PG-YBOCS), Timeline Follow-Back (TFB), questionário de crença de jogadores (GBQ), escala de impulsividade de Barratt (BIS-11), escala de impressão clínica global (CGI), escala de adequação social (EAS). Nos resultados, os pacientes que receberam topiramato obtiveram melhora nos escores das escalas: G-SAS, o que implica em redução dos sintomas de fissura e abstinência; PG-YBOCS, que mostrou redução de comportamentos e obsessões relacionados ao jogo; GBQ, que demonstrou redução de crenças supersticiosas e melhora cognitiva e EAS, que mostrou melhora na qualidade de vida. A entrevista TFB mostrou maiores reduções na média de tempo e quantia de dinheiro gasto em jogo no grupo topiramato em relação ao grupo placebo. Conclusão: o uso de topiramato associado a quatro sessões psicoeducacionais foi superior ao uso de placebo associado a quatro sessões psicoeducacionais, na redução de fissura, freqüência, comportamentos, superstições, quantidade de tempo e dinheiro destinados ao jogo, com melhora na qualidade de vida / Pathological gambling is an impulse control disorder that involves craving and impulsivity to gamble and in which gambling thoughts and behaviors may cause social impairment. Previous studies suggested that topiramate could be effective in the treatment of some disorders related to impulsivity, such as binge eating disorder, alcoholism or cocaine addiction. The studys main goal was to verify if topiramate was superior to placebo in controlling craving and reducing thoughts and behaviors related to gambling. Methods: pathological gamblers were randomized to topiramate (n=15) or placebo (n=15) in a 12-week, double-blind placebo controlled trial. During the 12 weeks the patients had four sessions of a program based on the 12 steps of Anonymous Gamblers. The primary outcome measure was the Gambling Symptom Assessment Scale (G-SAS), which evaluates symptoms related to abstinence. As secondary outcome measures it was used the following scales or interviews: Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS), Timeline Follow-Back Method (TFB), Gamblers Beliefs Questionnaire (GBQ), Barratt Impulsiveness Scale (BIS-11), Clinical Global Impression (CGI), Social Adjustment Scale (SAS). Results: There were statistic robust findings in some of the scales used in this study. The group of patients who took topiramate had improvement in the scores of the G-SAS, which implies reduction in the symptoms of craving and abstinence; PG-YBOCS, which showed reductions in the behaviors and obsessions related to gambling; GBG, which revealed reduction of superstitious thoughts and cognitive improvement, and EAS that showed improvement in the quality of life. TFB showed that the topiramate group had more reductions in the average of time and money spent on gambling than the placebo group. Conclusions: According to the results, topiramate associated with four sessions based in cognitive restructuring were superior to placebo associated with four sessions based in cognitive restructuring in reducing craving, frequency, behaviors and superstitions related to gambling, and amount of time and money used in gambling. Moreover, according to SAS, the group that took topiramate had better improvement in the quality of life than the placebo group

Le neurofeedback (NF) suscite actuellement un vif intérêt dans la prise en charge du trouble déficitaire de l’attention avec hyperactivité (TDAH) chez l’enfant. Proposée comme méthode alternative à la médication par de nombreux cliniciens, notamment aux États-Unis, le NF est une intervention non-invasive de type électrophysiologique qui repose sur l’apprentissage par conditionnement opérant de l’autorégulation d’ondes cérébrales déviantes. Les études empiriques qui étayent cette pratique font toutefois l’objet de virulentes critiques de la part de spécialistes dans le domaine du TDAH en raison de résultats systématiquement positifs mais non spécifiques, auxquels s’ajoutent de nombreuses lacunes méthodologiques. Les travaux de cette thèse visent à appliquer une méthodologie stricte de type essai clinique contrôlé avec assignation aléatoire afin d’isoler les effets particuliers du NF, en appliquant un protocole d’entraînement propre au déficit primaire sous-tendant le TDAH, soit l’inhibition motrice, dans le but d’évaluer la spécificité de cette intervention. Dans un premier temps, les connaissances relatives à la nosologie du TDAH, à ses principaux traitements, au NF et aux capacités d’inhibition chez l’enfant ayant un TDAH sont présentées (Chapitre 1). Ensuite, les études réalisées dans le cadre de cette thèse sont exposées. Dans l’étude initiale, la spécificité du NF est évaluée sur les capacités d’inhibition grâce à des mesures subjectives, soit des questionnaires de comportements complétés par les parents, ainsi que des mesures objectives, à savoir des tâches neuropsychologiques (Chapitre 2). Afin de préciser davantage les conséquences d’un entraînement à l’autorégulation d’ondes cérébrales, l’étude subséquente s’est intéressée à l’impact neurophysiologiques de l’amélioration des capacités d’inhibition, par le biais d’une étude en potentiels évoqués employant une tâche de performance continue de type Stop-signal (Chapitre 3). Les principaux résultats reflètent un recrutement sous optimal, avec une puissance statistique insuffisante pour réaliser des statistiques quantitatives de groupe. Néanmoins, l’appréciation des données selon une approche d’étude de cas multiples permet de mettre en évidence la présence d’une réponse placebo sur les capacités d’inhibition suite à un entraînement en NF. Finalement, les implications de la taille de l’échantillon, ainsi que les limites et les critiques de ces études sont discutées au Chapitre 4. / In recent years, there has been a lively interest in the use of neurofeedback (NF) as an alternative treatment to pharmacotherapy in pediatric Attention-deficit hyperactivity disorder (ADHD). NF is defined as an operant conditioning procedure whereby an individual learns to self-regulate electrical brain activity. Yet, empirical studies supporting its practice are harshly criticized in the field of ADHD research due to systematic unspecific positive results associated to numerous methodological flaws. Studies presented in this dissertation aim at applying a randomized placebo-controlled clinical trial to the investigation of NF specific effects. In order to further establish treatment specificity, we trained the participants using a NF protocol characteristic to motor-inhibition functioning since it has repeatedly been described as the core deficit in ADHD. The fist part of this thesis comprises a brief review of knowledge concerning ADHD, principal treatments offered for this disorder, NF research in pediatric ADHD and inhibition abilities in these children (Chapter 1). Following are the two studies conducted as part of this dissertation. In the initial study, effects of NF training are investigated on inhibition capacities by means of behavior rating scales and neuropsychological tests (Chapter 2). With the aim of further defining the consequence of training to self-regulate ones brain activity, the subsequent study looks at the neurophysiologic impact of improving inhibition capacities with an event-related potential study using a Stop-signal continuous performance task (Chapter 3). The principal results reveal a non optimal recruitment, with insufficient statistical power, thus precluding quantitative group statistics. Nevertheless, appreciating the data from a multiple case study perspective enables to suggest that a placebo response could be at play following NF training, such as measured by improvements on inhibition capacities. Finally, the implications of such a small sample size, limits and critics of these studies are discussed in Chapter 4.

O jogo patológico é classificado como um transtorno do controle dos impulsos, que envolve a fissura e a impulsividade para jogar, causando prejuízos sociais. Estudos prévios sugeriram que o topiramato poderia ser mais eficaz do que o placebo no tratamento de alguns transtornos relacionados com impulsividade, tais como transtorno de compulsão alimentar periódico, alcoolismo e dependência de cocaína. O principal objetivo deste estudo foi verificar se o topiramato foi superior ao placebo em controlar fissura e reduzir pensamentos e comportamentos relacionados ao jogo. Método: os jogadores patológicos foram aleatoriamente distribuídos em um de dois grupos: o que recebeu topiramato (n=15) e o que recebeu placebo (n=15) por 12 semanas. Durante o estudo, todos os pacientes participaram de quatro sessões psicoeducacionais, baseadas no programa de 12 passos dos jogadores anônimos. A principal variável de desfecho foi a escala G-SAS. As demais variáveis de desfecho foram consideradas secuindárias, sendo as escalas/entrevista: Escala Yale Brown de obsessão e compulsão adaptada para jogo patológico (PG-YBOCS), Timeline Follow-Back (TFB), questionário de crença de jogadores (GBQ), escala de impulsividade de Barratt (BIS-11), escala de impressão clínica global (CGI), escala de adequação social (EAS). Nos resultados, os pacientes que receberam topiramato obtiveram melhora nos escores das escalas: G-SAS, o que implica em redução dos sintomas de fissura e abstinência; PG-YBOCS, que mostrou redução de comportamentos e obsessões relacionados ao jogo; GBQ, que demonstrou redução de crenças supersticiosas e melhora cognitiva e EAS, que mostrou melhora na qualidade de vida. A entrevista TFB mostrou maiores reduções na média de tempo e quantia de dinheiro gasto em jogo no grupo topiramato em relação ao grupo placebo. Conclusão: o uso de topiramato associado a quatro sessões psicoeducacionais foi superior ao uso de placebo associado a quatro sessões psicoeducacionais, na redução de fissura, freqüência, comportamentos, superstições, quantidade de tempo e dinheiro destinados ao jogo, com melhora na qualidade de vida / Pathological gambling is an impulse control disorder that involves craving and impulsivity to gamble and in which gambling thoughts and behaviors may cause social impairment. Previous studies suggested that topiramate could be effective in the treatment of some disorders related to impulsivity, such as binge eating disorder, alcoholism or cocaine addiction. The studys main goal was to verify if topiramate was superior to placebo in controlling craving and reducing thoughts and behaviors related to gambling. Methods: pathological gamblers were randomized to topiramate (n=15) or placebo (n=15) in a 12-week, double-blind placebo controlled trial. During the 12 weeks the patients had four sessions of a program based on the 12 steps of Anonymous Gamblers. The primary outcome measure was the Gambling Symptom Assessment Scale (G-SAS), which evaluates symptoms related to abstinence. As secondary outcome measures it was used the following scales or interviews: Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS), Timeline Follow-Back Method (TFB), Gamblers Beliefs Questionnaire (GBQ), Barratt Impulsiveness Scale (BIS-11), Clinical Global Impression (CGI), Social Adjustment Scale (SAS). Results: There were statistic robust findings in some of the scales used in this study. The group of patients who took topiramate had improvement in the scores of the G-SAS, which implies reduction in the symptoms of craving and abstinence; PG-YBOCS, which showed reductions in the behaviors and obsessions related to gambling; GBG, which revealed reduction of superstitious thoughts and cognitive improvement, and EAS that showed improvement in the quality of life. TFB showed that the topiramate group had more reductions in the average of time and money spent on gambling than the placebo group. Conclusions: According to the results, topiramate associated with four sessions based in cognitive restructuring were superior to placebo associated with four sessions based in cognitive restructuring in reducing craving, frequency, behaviors and superstitions related to gambling, and amount of time and money used in gambling. Moreover, according to SAS, the group that took topiramate had better improvement in the quality of life than the placebo group

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