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临床试验/NCT03456986
NCT03456986撤回不适用

Improvements in Cognitive Skills of Older Adults Using Dynamic Visual Attention Training

Perception Dynamics Institute4 个研究点 分布在 1 个国家开始时间: 2018年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
4
主要终点
Reading Speed

研究概览

简要总结

The proposed SBIR Phase I study tests the feasibility of PATH neurotraining for improving cognitive skills in older adults and, potentially, forestalling or protecting against cognitive decline and dementia. The feasibility of PATH neurotraining will be evaluated by comparing it with another cognitive training program, Brain HQ's Target Tracker, and ascertaining the relative advantage(s) of PATH neurotraining for enhancing cognition in older adults between 55 and 75 years of age whose cognition is either in the age-normative range or in the mild cognitive impairment (MCI) range of standardized psychometric measures. MEG/MRI source imaging will be used on 12 of the PATH group participants to determine whether the behavioral results are verified by improvements in the dorsal, attention, and executive control networks.

详细描述

The goal of this study is to show that neurotraining in the center of the motion working range (PATH) that improves the contrast sensitivity for direction discrimination (dorsal stream activity significantly improves cognitive skills in older adults more than in those who do training to improve orientation discrimination: ventral stream activity (sham training). Brain training will be administered for 20 minutes three times a week for 12 weeks: Arm 1) PATH neurotraining and Arm 2) Sham training. The investigators predict that older adults who do PATH neurotraining will improve their visual and cognitive skills, improving attention, multitasking, processing speed, reading fluency, and working memory, significantly more than those doing sham training. This prediction will be evaluated by measuring whether older adults improve on standardized tests of cognitive skills following PATH neurotraining more than older adults doing orientation discrimination training to improve processing speed and attention. MEG brain imaging will be used to show that PATH training improves the dorsal, attention, and executive control networks, as found previously, more than does sham training. The investigators predict these improvements will be found in both healthy adults and those with MCI.

The feasibility of rapid, effective brain training will be evaluated by using behavioral methods to remediate age-related cognitive decline, and to treat the cognitive impairment and/or behavioral symptoms associated with MCI, as well as to slow and/or reverse the course of cognitive decline or to prevent it entirely. PATH neurotraining provides a computer-based product to remediate the visual and cognitive difficulties of older adults rapidly and effectively. The innovative PATH neurotraining improves the center of the motion working range, whereas the sham training improves the center of the orientation discrimination working range. The two brain training groups will be balanced, in terms of healthy older adults and those with MCI. A subject will be considered to have MCI if the WAIS Working Memory Index score is less than 50 percent, and the MOCA has a score of 19-25. These groups will also be balanced in terms of age and reading speed, a sensitive measure of processing speed.

Half of the older adults will complete the PATH neurotraining for 12 weeks and half will complete sham training for 12 weeks. An additional 12 weeks will be needed to train staff, recruit subjects, and complete the standardized tests and MEG imaging. The choice of which adults will do each type of brain training will be randomized, to be determined by study statistician Prof. John Shelley-Tremblay. After initial standardized testing, 12 adults doing PATH training will be selected for pre-post MEG brain imaging.

Precise measurements using pre- and post- standardized tests of cognitive skills will be used to validate the improved visual and cognitive (attention, processing speed, and memory) performance reported previously in older adults. Standardized tests and MEG imaging on a subset will be administered by staff before and after cognitive training to evaluate improvements in cognitive skills following treatment (PATH neurotraining) and control (sham training) interventions.

Evaluating improvements in cognitive skills of older adults will be grouped by subject type: whether the adult is healthy or has MCI to determine which intervention improves cognitive skills the most. The investigators predict that PATH neurotraining will significantly improve (at p ≤ 0.05) reading speed, working memory and attention (cognitive flexibility) in older adults more than after training on sham training. This will be evaluated by both: 1) measuring whether older adults improve on the standardized tests listed above following brain training, and 2) MEG brain source imaging to validate that dorsal stream, attention, and executive control networks improve in function significantly following PATH neurotraining.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

All data will be encrypted so participant's ID does not identify person. Two interventions, both improving motion discrimination will be investigated. Both have the potential of improving cognitive skills, so staff will not think one works better than the other. All data will be input by the senior research assistants who will not know what group a participant belonged to.

入排标准

年龄范围
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All older adults who want to participate and can do the intervention tasks, agree to the time commitment, and are not excluded for reasons cited below

排除标准

  • Have severe depressions or suicidal thoughts or tendencies
  • Have had a stroke, Traumatic Brain Injury, or metabolic derangements causing cognitive impairments, such as alcohol or substance abuse.
  • Cannot complete the PATH neurotraining task, pushing the left or right arrow key on the computer after moving patterns are presented briefly on the computer screen will be excluded. That has never been a problem previously, so we do not anticipate excluding anyone for this reason.
  • Cannot drive to the test site, eliminating those with major functional issues in cognition.
  • Have been given a diagnosis of dementia by their doctor.
  • Do not agree to complete the study after hearing the time commitment involved.
  • For the MEG portion of study, have extensive metal dental hardware )e.g. braces and large metal dentures; fillings are acceptable) or other metal objects in the head, neck, or face areas that cause artifacts in the MEG data, not removable during pre-processing

结局指标

主要结局

Reading Speed

时间窗: 12 weeks (before and after intervention training)

Number of words/minute subject can read 6 words of text from interesting story. Measures improvements in processing speed.

次要结局

  • ACC Function(12 weeks (before and after intervention training))
  • DLPFC Function(12 weeks (before and after intervention training))
  • Visual Working Memory(12 weeks (before and after intervention training))
  • Attention Switching(12 weeks (before and after intervention training))
  • Precuneus/PCC(12 weeks (before and after intervention training))
  • Auditory Working Memory(12 weeks (before and after intervention training))
  • Processing Speed(12 weeks (before and after intervention training))
  • Attention(12 weeks (before and after intervention training))

研究者

发起方
Perception Dynamics Institute
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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