Study Stopped
Study was never funded by NIH as anticipated.
Improvements in Cognitive Skills of Older Adults Using Dynamic Visual Attention Training
1 other identifier
interventional
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2018
CompletedFirst Posted
Study publicly available on registry
March 7, 2018
CompletedStudy Start
First participant enrolled
September 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedMarch 4, 2020
April 1, 2018
8 months
February 22, 2018
March 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Reading Speed
Number of words/minute subject can read 6 words of text from interesting story. Measures improvements in processing speed.
12 weeks (before and after intervention training)
Secondary Outcomes (8)
Auditory Working Memory
12 weeks (before and after intervention training)
Visual Working Memory
12 weeks (before and after intervention training)
Attention
12 weeks (before and after intervention training)
Attention Switching
12 weeks (before and after intervention training)
Processing Speed
12 weeks (before and after intervention training)
- +3 more secondary outcomes
Study Arms (2)
PATH neurotraining (treatment)
EXPERIMENTALSubject 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.
Orientation Discrimination (control)
ACTIVE COMPARATORSubject looks at computer screen to determine whether bars in center circular window are tilted left or right relative to vertically oriented background bars. The subject reports which way center pattern is tilted by pushing left or right arrow key, receiving brief tone if incorrect. Program adaptively changes orientation of test pattern in order to keep subject at 79% correct. There are levels of difficulty introduced by making the background pattern colored or black and white, and by increasing pattern's complexity level. This Intervention will be trained for one training cycle, between 10-20 minutes, 3 times each week for 12 weeks.
Interventions
Tunes up the center of the motion discrimination (dorsal stream) working range
Tunes up the ventral stream most sensitive to high contrast and colored patterns.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Perception Dynamics Institutelead
- University of California, San Diegocollaborator
- University of South Alabamacollaborator
Study Sites (2)
UCSD Radiology Laboratory
La Jolla, California, 92093, United States
Perception Dynamics Institute
Solana Beach, California, 92075, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Teri Lawton, PhD
Perception Dynamics Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2018
First Posted
March 7, 2018
Study Start
September 4, 2018
Primary Completion
April 30, 2019
Study Completion
September 30, 2021
Last Updated
March 4, 2020
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- May 2019 for 10 years.
- Access Criteria
- Qualified investigator
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.