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

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ClinicalTrials.gov Identifier: NCT03456986
Recruitment Status : Not yet recruiting
First Posted : March 7, 2018
Last Update Posted : April 9, 2018
Sponsor:
Collaborators:
University of California, San Diego
University of South Alabama
Information provided by (Responsible Party):
Perception Dynamics Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Age Related Cognitive Decline Behavioral: PATH neurotraining Behavioral: Brain HQ Target Tracker Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Improvements in Cognitive Skills of Older Adults Using Dynamic Visual Attention Training
Estimated Study Start Date : September 4, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : September 30, 2021

Arm Intervention/treatment
Experimental: PATH neurotraining
Subject looks at computer screen to determine whether bars in fish-shaped window move left or right relative to background bars. The subject reports which way center pattern moves by pushing left or right arrow key, receiving brief tone if incorrect. Program adaptively changes contrast of test pattern in order to keep subject at 79% correct. There are levels of difficulty introduced by making the background pattern more similar to that in fish, by increasing pattern's complexity level, and by increasing number of directions of movement from one to two directions of motion. Intervention will be trained for one training cycle, between 10-20 minutes, 3 times each week for 12 weeks.
Behavioral: PATH neurotraining
Tunes up the center of the motion discrimination working range

Active Comparator: Brain HQ Target Tracker
To do Target Tracker, the subject starts by seeing a few target and distractor objects on the screen. Subject's job: to keep track of the targets as all the objects move around the screen. When the objects stop moving, subject clicks on each target to identify it. As subject moves through the cognitive training exercise, it gets harder by: 1) objects travel more quickly, for longer amounts of time, and over larger areas, 2) contrast between the objects and background decreases, making it harder to track targets, 3) adds to number of objects being tracked if subject's successful and subtracts from the number if subject's struggling. Target Tracker limited to 20 minutes each time.
Behavioral: Brain HQ Target Tracker
Tunes up the limits of the motion discrimination working range




Primary Outcome Measures :
  1. Reading Speed [ Time Frame: 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.


Secondary Outcome Measures :
  1. Auditory Working Memory [ Time Frame: 12 weeks (before and after intervention training) ]
    The WAIS Working Memory Index Standardized Percentile Rank that goes from < 0.1% to > 99.9%

  2. Visual Working Memory [ Time Frame: 12 weeks (before and after intervention training) ]
    The Test of Information Processing Skills Visual Working Memory Standardized Percentile Rank that goes from < 1% to > 99%

  3. Attention [ Time Frame: 12 weeks (before and after intervention training) ]
    DKEFS Color-Word Interference Test standardized scores for Inhibition Scaled Scores that go from 1 to 19 converted to Standardized Percentile Rank from 0.5% to 99.9%

  4. Attention Switching [ Time Frame: 12 weeks (before and after intervention training) ]
    DKEFS Color-Word Interference Test standardized scores for Inhibition Switching Scaled Scores that go from 1 to 19 converted to Standardized Percentile Rank from 0.5% to 99.9%

  5. Processing Speed [ Time Frame: 12 weeks (before and after intervention training) ]
    WAIS Processing Speed Index Standardized Percentile Rank that goes from < 0.1% to > 99.9%

  6. DLPFC Function [ Time Frame: 12 weeks (before and after intervention training) ]
    Using the total covariance matrix, voxel-wise MEG source magnitude images that cover the whole brain will be obtained for each subject, and each frequency band, following the Fast-VESTAL procedure, measuring time-locked signals during a working memory N-back task to evaluate improvements in brain function in DLPFC (working memory).

  7. ACC Function [ Time Frame: 12 weeks (before and after intervention training) ]
    Using the total covariance matrix, voxel-wise MEG source magnitude images that cover the whole brain will be obtained for each subject, and each frequency band, following the Fast-VESTAL procedure, measuring time-locked signals during a working memory N-back task to evaluate improvements in brain function in ACC (attention network).

  8. Precuneus/PCC [ Time Frame: 12 weeks (before and after intervention training) ]
    Using the total covariance matrix, voxel-wise MEG source magnitude images that cover the whole brain will be obtained for each subject, and each frequency band, following the Fast-VESTAL procedure, measuring time-locked signals during a working memory N-back task to evaluate improvements in brain function in Precuneus/PCC (attention network).



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT03456986


Contacts
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Contact: Teri Lawton, PhD 310-903-6009 tlawton@pathtoreading.com
Contact: Mingxiong Huang, PhD 858-534-1254 mxhuang@ucsd.edu

Locations
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United States, California
UCSD Radiology Laboratory Not yet recruiting
La Jolla, California, United States, 92093
Contact: Mingxiong Huang, PhD    858-534-1254    mxhuang@ucsd.edu   
Contact: Teri Lawton, PhD    310-903-6009    tlawton@pathtoreading.com   
Perception Dynamics Institute Not yet recruiting
Solana Beach, California, United States, 92075
Contact: Teri Lawton, PhD    310-903-6009    tlawton@pathtoreading.com   
Contact: Mingxiong Huang, PhD    858-534-1254    mxhuang@ucsd.edu   
Sponsors and Collaborators
Perception Dynamics Institute
University of California, San Diego
University of South Alabama

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Responsible Party: Perception Dynamics Institute
ClinicalTrials.gov Identifier: NCT03456986     History of Changes
Other Study ID Numbers: 1R43 AG059547-01
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After completion of the study, deidentified data will be made available to qualified outside investigators following NIH Data Sharing guidelines; none of the data will be considered proprietary. Most of the data for this study will be collected through standardized tests of attention, processing speed, and working memory to be administered by the staff on this project.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: May 2019 for 10 years.
Access Criteria: Qualified investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders