- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04905849
Enhancing Cognitive Control Abilities Using Mobile Technology in a Senior Living Community (Senior Living)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94158
- UC San Francisco
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must be living at a Senior Living Community
- have own iPad and/or smartphone,
- native-English speaker.
Participation across a spectrum of cognitive abilities is desired for this study, specifically for older adults in a community setting.
Exclusion Criteria:
- Do not have any physical or cognitive limitations that would clearly prevent them from utilizing these applications as intended
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adaptive Cognitive Control Trainer (ACCT)
There are three modules within the game, each training a different aspect of cognitive control (attention, goal management, working memory): a visual search task for attention abilities, a spatial span task for working memory, and a task switching paradigm for goal management abilities.
There are also 3 different levels of difficulty associated with each module; advancing to the next level delivers an advanced challenge that enhances the difficulty in performing the given cognitive task.
Participants advance to the next level of difficulty following 6 training sessions occurring over 2 weeks, with the total training experience being 6 weeks of training (3 days/week), with each training session lasting 36 minutes (not including self-paced breaks).
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Module 1: Attention=> This module demands an active scan of the screen in search for a target, much like traditional visual search tasks. Participants quickly identify the direction that a probe target is facing (up, down, left, right), and are aided by the presence of directional cue indicating where the location of the target will appear. Module 2: Goal Management=> Requires participants to rapidly switch their focus based on distinct rules. Participants are presented with exemplar objects along with a target, and are asked to indicate which exemplar presented is most like the target. Module 3: Working Memory=> Engages spatial working memory resources similar to the Corsi block task. Participants memorize the location of objects on screen followed by a 5-7 second delay period, with a correct response leading to a greater number of potential targets to be memorized on the next trial (and vice versa). |
Active Comparator: Active Control Group
An active control application will be used for this arm.
The total training experience here will also be for 6 weeks (3 days/week), with each training session lasting ~30 minutes (not including self-paced breaks).
Here an app that is matched in terms of expectancy of benefits compared to our training groups will be determined by questioning 100 naïve individuals to predict their expected improvement on each cognitive domain across a multitude of possible applications.
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The app used here is undergoing expectancy-matching at the present time, will be updated with the final app characteristics when completed out of a list of several possibilities
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change on Adaptive Cognitive Evaluation (ACE) from Baseline at 6 weeks
Time Frame: At Baseline and post intervention at the 6 week mark
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ACE is a custom mobile cognitive health assessment battery that presents paradigms typically used in standard cognitive neuroscience laboratories.
Here the investigators will assess a measure of (1) Attention (2) Working memory, and (3) Goal management in the ACE software.
We will assess response time, accuracy, and response time variability in each case, with faster/more accurate/less variable performance being indicative of improved cognitive control.
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At Baseline and post intervention at the 6 week mark
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change on Everyday Cognition Scale (ECog) from Baseline at 6 weeks
Time Frame: At Baseline and post intervention at the 6 week mark
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The Everyday Cognition Scale (ECog) measures the ability to perform everyday tasks that demand memory, language, visuospatial abilities, planning, organization, and divided attention.
The ECog consists of a global and domain scores for each of the previously described categories, and is scored as follows: 1= better or no change compared to 10 years earlier, 2= questionable/occasionally worse compared to 10 years earlier, 3= consistently a little worse compared to 10 years earlier, 4= consistently much worse compared to 10 years earlier.
Thus, the lower the overall score is on this measure at both the global and domain score level, the better one is performing with respect to their cognition.
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At Baseline and post intervention at the 6 week mark
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Mean Change on Cognitive Failures Questionnaire (CFQ) from Baseline at 6 weeks
Time Frame: At Baseline and post intervention at the 6 week mark
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The Cognitive Failures Questionnaire (CFQ) assesses participant distractibility.
The CFQ score ranges from 0 to 100, with the lower the overall score is on this measure, the better one is performing with respect to their cognition.
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At Baseline and post intervention at the 6 week mark
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Mean Change on General health and well-being (SF-36) from Baseline at 6 weeks
Time Frame: At Baseline and post intervention at the 6 week mark
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The general health and well-being (SF-36) score assesses participant health.
The SF-36 score ranges from 0 to 100.
The higher the overall score is on this measure, the better one is performing with respect to their health and well-being.
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At Baseline and post intervention at the 6 week mark
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Joaquin Anguera, Ph.D., UC San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R21AG058896 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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