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Vision-based Speed of Processing Cognitive Training and Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT02559063
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Vankee Lin, University of Rochester

Brief Summary:
This project seeks to identify neural changes that occur in adults with mild cognitive impairment (MCI) after engagement in computerized cognitive training. In addition, this project aims to identify physiological factors that may bolster effects of the training on cognitive function. Individuals with MCI are at high risk for Alzheimer's disease (AD). Understanding how cognitive training protects cognitive function in MCI can contribute to development of effective interventions to slow progression to AD in individuals at risk, thereby reducing the significant morbidity and health care costs associated with AD.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Vision-based speed of processing training Behavioral: Mental leisure activities Not Applicable

Detailed Description:
Mild Cognitive Impairment (MCI), especially amnestic type, is considered a symptomatic pre-Alzheimer's disease (AD) phase, and is prevalent in the aging population. Vision-based speed of processing (VSOP) cognitive training is one of the most widely applied behavioral interventions in community-dwelling older Americans free of AD, holding potential to slow cognitive decline. Its particular relevance to MCI is supported by converging evidence from our preliminary studies, including a recently completed pilot intervention study. However, we know little about the mechanisms underlying the benefits of VSOP training, limiting our ability to further exploit VSOP or other forms of cognitive training. In particular, we do not know if and how the effects of VSOP training on cognitive performance are mediated by neuroplasticity-related brain changes. Since recent evidence suggests that neuroplasticity is inducible throughout adult life, even in MCI, it is possible that VSOP training promotes neuroplasticity and slows neurodegeneration. In this early stage and new investigator application, we will focus on assessing whether and how VSOP training, relative to mental leisure activities (MLA), alters cognitive and neural functions in older adults with MCI, up to 6 months after training. The study will enroll and randomize 84 participants with amnestic MCI to VSOP training or MLA control groups. Three specific research aims are to (1) determine whether VSOP training improves processing speed and attention that are associated with changes of brain structural and functional connectivity; (2) test a novel neurophysiological pathway of VSOP training effect on brain structure and function; (3) examine the effect of VSOP training on untrained cognitive and functional domains and the role of neurophysiological changes underlying possible transfer effects. By examining multiple neural and novel physiological mechanisms linking a promising VSOP training intervention to improvements in cognitive performance, this application seeks to challenge and shift current research on cognitive training that merely examines training effects on cognitive outcomes. Discovery of neural, and physiological-related mechanisms in VSOP training will have important implications beyond this particular intervention. Findings from recent behavioral studies (e.g., cognitive intervention, physical exercise, nutrition, and bio-feedback intervention) suggest that for cognitive decline to be mitigated in individuals at risk for AD, it will be necessary for interventions to target the neural and peripheral physiological pathways that are susceptible to AD neuropathology. Confirmation of the study hypotheses could support immediate translation to clinical practices by demonstrating the efficacy, sustainability, and generalizability of cognitive training.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Neurophysiological Aspects of Vision-based Speed of Processing Cognitive Training in Older Adults With Mild Cognitive Impairment
Actual Study Start Date : January 12, 2016
Actual Primary Completion Date : October 9, 2018
Actual Study Completion Date : July 1, 2019

Arm Intervention/treatment
Experimental: Vision-based speed of processing
Vision-based speed of processing training will use the INSIGHT online program (Posit Science), which includes five games (i.e., Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All games share visual components, and the tasks become increasingly more difficult and require faster reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
Behavioral: Vision-based speed of processing training
computerized cognitive tasks addressing vision-based speed of processing

Active Comparator: Mental leisure activities
Mental leisure activities control activities were chosen to: 1) control for computer, online experience [and amount of time]; 2) not induce acute stress (i.e., without time management, speed component, or novel cognitive stimuli); 3) simulate participants' everyday mental activities; and 4) entertain participants to keep them from dropping out. Cross-word, Sudoku, and solitaire games will be used, which were also used in previous VSOP training study as control exercises. Participants can choose to practice any combination of games. At the end of their participation, the MLA control group will be provided with free 6-week access to the VSOP training program.
Behavioral: Mental leisure activities
computerized cognitive tasks addressing different aspects of executive function




Primary Outcome Measures :
  1. Attention and processing speed test (UFOV) [ Time Frame: change from baseline to 6-month follow-up ]

Secondary Outcome Measures :
  1. Cognitive control and working memory (EXAMINER) [ Time Frame: change from baseline to 6-month follow-up ]
  2. instrumental activities of daily living (TIADL) [ Time Frame: change from baseline to 6-month follow-up ]
  3. mean of functional connectivity in default mode network [ Time Frame: change from baseline to 6-month follow-up ]
    Resting state fMRI will be used to assess the functional connectivity of the neural network. SPM will be used to analyze and determine the change of the connectivity over time.

  4. mean of structural connectivity in default mode network [ Time Frame: change from baseline to 6-month follow-up ]
    Diffusion tensor imaging will be used to assess the structural connectivity of the neural network. FSL will be used to analyze and determine the change of the connectivity over time.


Other Outcome Measures:
  1. long-term visual memory [ Time Frame: change from baseline to 6-month follow-up ]
    long-term visual memory will be assessed using Brief Visuospatial Memory Test (BVMT)-R.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • a clinical diagnosis of "mild cognitive impairment due to Alzheimer's disease" using the most recent NIA and Alzheimer's Association workshop criteria within 3 months: a) must have memory deficit (1-1.5SD below age- and education-corrected population norms); b) may have deficits in other cognitive domains (e.g., executive function); c) preserved BADL, defined as requiring occasional assistance on less than two items on the Minimum Data Set-Home Care interview, d) absence of dementia using NINCDS-ADRDA criteria;
  • if on AD medication (i.e., memantine or cholinesterase inhibitors), no changes of doses in the 3 months prior to recruitment;
  • capacity to give consent based on clinician assessment; and
  • other: age ≥60 years, English-speaking, adequate visual acuity for testing, and community-dwelling.

Exclusion Criteria:

  • current enrollment in another cognitive improvement study;
  • major depression: 15-item Geriatric Depression Scale scored > 7;
  • MRI contraindications, e.g., metallic implant, pacemaker, claustrophobia; and
  • major vascular diseases: stroke, myocardial infarction, congestive heart failure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559063


Locations
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United States, New York
University of Rochester Memory Care Program
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Vankee Lin, PhD University of Rochester
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Responsible Party: Vankee Lin, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT02559063    
Other Study ID Numbers: 1R01NR015452 ( U.S. NIH Grant/Contract )
1R01NR015452 ( U.S. NIH Grant/Contract )
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Keywords provided by Vankee Lin, University of Rochester:
cognitive training
speed of processing
neuroplasticity
cognitive aging
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders