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。发病时通常 发生在年轻的成年期，精神分裂症患者往往难以建立和维持社会关系， 在社区中的工作角色。认识到精神分裂症的严重残疾， 退伍军人健康管理局优先向患有严重精神疾病的成年人提供精神卫生保健服务。 和持续的精神疾病总统的新自由委员会呼吁发展 精神卫生保健服务，重点是“提高消费者成功科普生活的能力 挑战，促进复苏和建设复原力。 拟议的干预研究旨在增强认知，并最终，心理社会功能， 患者与精神分裂症相关的认知功能障碍已被发现是最严重的 预测患者在社区中的表现。这项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的新型配对的疗效 精神分裂症目前，认知补救，一种基于计算机的干预， 能力，是一种干预方法，在改变认知表现方面取得了最大的成功， 精神分裂症患者虽然这一干预办法取得了进展，但其影响是， 适度，这种方法所需的训练方案的强度可能是限制 广泛使用这种干预措施。经颅直流电刺激（tDCS）是一种神经调节性刺激， 已经发现暂时促进学习和提高认知能力的技术。的 拟议的研究将检查这两种技术结合使用，以提高认知和心理社会 在精神分裂症患者中发挥作用。 为了实现这一目标，100名精神分裂症患者将被随机分配到认知矫正组， 不管是tDCS还是假的在这两种情况下，参与者都将接受基于计算机的认知测试。 训练和元认知策略训练，每周三次，共16周。认知训练方案 在这项研究中提出的是侧重于锻炼工作记忆的过程，并已被发现是有效的 in producing生产change更改in this domain域.处于tDCS条件下的参与者将接受20分钟的1 mA电流 刺激与训练同时进行。假条件下的参与者将接受30秒的刺激， 模拟tDCS的体验。我们假设，与假条件下的参与者相比， 接受tDCS认知补救的患者将在以下方面表现出显著更大的变化： 工作记忆、相关认知功能、功能能力和 社区功能。第二个研究目标是检查干预引起的变化的稳定性， 认知.将在治疗终止后6周和6个月（26周）对受试者进行重新评估， 检查干预引起的变化的稳定性。我们假设训练引起了 认知将是稳定的，接受tDCS认知训练的参与者将保持 预测整个随访期间的组间差异。此外，本研究将在一个 探索性的方式是否在认知训练的表现个体差异是预测 干预引起的变化的规模和广度。最后，认知矫正的参与经验 将密切评估tDCS和假手术的患者，以确定对干预程序的反应， 在临床实践中实施的障碍。预计与会者将报告，这些程序是 可忍受的，值得的，令人愉快的。实现这些目标将为干预措施的制定工作提供信息， 评估安全、非侵入性和负担得起的认知辅助治疗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.