title: The efficacy of Cognitive training in patients with VAsCular Cognitive Impairment, No dEmentia (the Cog-VACCINE study): study protocol for a randomized controlled trial.
abstract: Vascular cognitive impairment, no dementia (VCIND) refers to cognitive deficits associated with underlying vascular causes that fall short of a dementia diagnosis. There is currently no treatment for VCIND. Computerized cognitive training, which has significantly improved cognitive function in healthy older adults and patients with cognitive impairment has not yet been applied to VCIND.
  
  
  
  The proposed study is a three-center, double-blinded, randomized controlled trial that will include 60 patients with VCIND. The patients will be randomized to either a training or a control group. The intervention is internet-based cognitive training performed for 30 min over 35 sessions. Neuropsychological assessment and functional and structural MRI will be performed before and after 7 weeks training. Primary outcomes are global cognitive function and executive function. Secondary outcome measures are neuroplasticity changes measured by functional and structural MRI.
  
  
  
  Applying an internet-based, multi-domain, adaptive program, this study aims to assess whether cognitive training improves cognitive abilities and neural plasticity in patients with subcortical VCIND. In addition to the comprehensive assessment of the participants by neuropsychological tests, cerebrovascular risk factors and apolipoprotein E genotyping, neuroplasticity will be used as an evaluation outcome in this study for, to our knowledge, the first time. The combination of functional and structural MRI and neuropsychological tests will have strong sensitivity in evaluating the effects of cognitive training and will also reveal the underlying mechanisms at work.
  
  
  
  ClinicalTrials.gov NCT02640716 . Retrospectively registered on 21 December 2015.
authors: Department of Neurology, Xuan Wu Hospital, Capital Medical University, 45 Changchun Street, Beijing, 100053, China. tangyixw@163.com.
authors: Yi
authors: Y
authors: Tang
authors: Collaborative Innovation Center for Language Competence, Jiangsu Normal University, Xuzhou, Jiangsu, China.
authors: Zude
authors: Z
authors: Zhu
authors: Department of Neurology, Xuan Wu Hospital, Capital Medical University, 45 Changchun Street, Beijing, 100053, China.
authors: Qing
authors: Q
authors: Liu
authors: Department of Geriatric Medicine, Fu Xing Hospital, Capital Medical University, Beijing, China.
authors: Fang
authors: F
authors: Li
authors: Department of Neurology, Xuan Wu Hospital, Capital Medical University, 45 Changchun Street, Beijing, 100053, China.
authors: Jianwei
authors: J
authors: Yang
authors: Department of Neurology, Xuan Wu Hospital, Capital Medical University, 45 Changchun Street, Beijing, 100053, China.
authors: Fangyu
authors: F
authors: Li
authors: Department of Neurology, Xuan Wu Hospital, Capital Medical University, 45 Changchun Street, Beijing, 100053, China.
authors: Yi
authors: Y
authors: Xing
authors: Department of Neurology, Xuan Wu Hospital, Capital Medical University, 45 Changchun Street, Beijing, 100053, China. jiajp@vip.126.com.|Department of Neurology, Beijing Friendship Hospital, Capital Medical University, Beijing, China. jiajp@vip.126.com.
authors: Jianping
authors: J
authors: Jia
mesh_terms: D001921:Brain / Q000000981:diagnostic imaging / Q000503:physiopathology*; D002561:Cerebrovascular Disorders / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D002681:China; D002985:Clinical Protocols; D003071:Cognition; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D060825:Cognitive Dysfunction / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D004311:Double-Blind Method; D056344:Executive Function; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009473:Neuronal Plasticity; D009483:Neuropsychological Tests; D020127:Recovery of Function; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
keywords: Cognitive training; Magnetic resonance imaging; Neuroplasticity; No dementia; Protocol; Randomized controlled clinical trial; Vascular cognitive impairment