Restoration of Cognitive Function with TDCS and Training in Schizophrenia

精神分裂症是世界上成年人最致残的疾病之一。通常以发病为特征 精神分裂症患者发生在青年时期，通常难以建立和维持社会和 社区中的工作角色。为了认识到与精神分裂症有关的严重残疾， 退伍军人健康管理局优先为患有严重疾病的成年人提供精神卫生保健服务 以及持续性的精神疾病。总统的新自由委员会呼吁制定 以“提高消费者成功应对生活的能力”为重点的精神卫生保健服务 挑战、促进复苏和建立复原力。“ 这项拟议的干预研究旨在增强认知，并最终增强患者的心理社会功能。 病人。与精神分裂症相关的认知功能障碍被发现是最严重的之一 预测患者在社区中表现如何的指标。拟议研究的主要目的是评估 旨在恢复患者认知功能的两种治疗干预措施的新组合的有效性 患有精神分裂症。目前，认知补救，一种基于计算机的干预，练习认知 能力是一种干预方法，在改变认知表现方面表现出最大的成功 精神分裂症患者。虽然这种干预方法取得了进展，但其影响是 适中，这种方法所需的训练方案的强度可能是限制 这种干预的广泛使用。经颅直流电刺激是一种神经调节性刺激。 已被发现可以暂时促进学习和提高认知能力的技术。这个 拟议中的研究将检查这两种技术结合使用来增强认知和心理社会 精神分裂症患者的功能。 为了实现这一目标，100名精神分裂症患者将被随机配对接受认知治疗 无论是tdcs还是假病症。在这两种情况下，参与者都将接受基于计算机的认知 每周三次培训和元认知策略培训，为期16周。认知训练方案 这项研究提出的重点是锻炼工作记忆过程，并已被发现是有效的 在这一领域产生变革。在tdcs条件下的参与者将获得20分钟的1 mA 在训练的同时进行刺激。在假状态下的参与者将接受30秒的刺激 模拟tdcs的使用体验。我们假设，与处于假状态的参与者相比， 接受tdcs认知治疗的患者将在 神经心理学测量工作记忆、相关认知功能、功能容量和 社区运作。第二个研究目标是检查干预引起的变化的稳定性 认知力。参与者将在治疗结束后6周和6个月(26周)重新评估 检验干预引起的变化的稳定性。我们假设训练引起的变化 认知将是稳定的，接受TDC认知训练的参与者将保持 在整个随访期内预测组间差异。此外，这项研究将在一项 探索性方式：个体在认知训练上的表现差异是否可以预测 干预引起的变化的幅度和广度。最后，认知补救的参与者体验 将对TDC和SHAM进行密切评估，以确定对干预程序的反应 在临床实践中实施的障碍。预计参与者应报告程序是 可容忍的、值得的和令人愉快的。实现这些目标将为干预发展工作提供信息，通过 评估一种安全、非侵入性和负担得起的认知辅助工具的有效性和可接受性 补救措施。

Schizophrenia is among the most disabling illnesses of adults in the world. With illness onset typically occurring in young adulthood, individuals with schizophrenia often struggle to establish and maintain social and work roles in the community. In recognition of the profound disability associated with schizophrenia, the Veteran’s Health Administration has prioritized provision of mental health care services to adults with severe and persistent mental illnesses. The President’s New Freedom Commission called for the development of mental health care services that focus on “increasing consumer’s ability to successfully cope with life challenges, on facilitating recovery, and on building resilience.” The proposed intervention study is designed to enhance cognition, and ultimately, psychosocial functioning in patients. The cognitive dysfunction associated with schizophrenia has been found to be one of the strongest predictors of how well patients do in the community. The primary aim of the proposed study is to evaluate the efficacy of a novel pairing of two therapeutic interventions designed to restore cognitive functioning in patients with schizophrenia. Presently, cognitive remediation, a computer-based intervention that exercises cognitive abilities, is the approach to intervention that has shown the most success in changing cognitive performance in patients with schizophrenia. While gains are made with this approach to intervention, the impact has been modest, and the intensity of training regimens required by this approach may be a barrier that limits widespread use of this intervention. Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that has been found to temporarily facilitate learning and to enhance cognitive performance. The proposed study will examine these two techniques used in combination to enhance cognition and psychosocial functioning in patients with schizophrenia. To accomplish this goal, 100 patients with schizophrenia will be randomized to cognitive remediation paired with either tDCS or a sham condition. In both conditions participants will receive computer-based cognitive training and metacognitive strategy training three times a week for 16 weeks. The cognitive training protocol proposed in this study is focused on exercising working memory processes and has been found to be effective in producing change in this domain. Participants in the tDCS condition will receive 20 minutes of 1 mA stimulation concurrent with training. Participants in the sham condition will receive 30 seconds of stimulation to simulate the experience of tDCS. We hypothesize that, as compared to participants in the sham condition, patients who receive cognitive remediation with tDCS will demonstrate significantly greater change on neuropsychological measures of working memory, related cognitive functions, functional capacity, and community functioning. A second study goal is to examine the stability of intervention-induced change in cognition. Participants will be re-assessed 6 weeks and 6 months (26 weeks) after treatment termination to examine the stability of intervention induced change. We hypothesize that training induced changes in cognition will be stable and that participants who receive cognitive training with tDCS will maintain the predicted between-group difference throughout the follow up period. In addition, this study will examine in an exploratory manner whether individual differences in performance on the cognitive training are predictive of magnitude and breadth of intervention-induced change. Last, participant experience of cognitive remediation with tDCS and sham will be closely assessed to identify reactions to the intervention procedures that could be a barrier to implementation in clinical practice. Participants are expected to report that the procedures are tolerable, worthwhile, and enjoyable. Achieving these objectives will inform intervention development efforts by evaluating the efficacy and acceptability of a safe, non-invasive, and affordable adjunct to cognitive remediation.