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Training to Enhance Cognition in Older Adults

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ClinicalTrials.gov Identifier: NCT03900702
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Jeanne Townsend, PhD, University of California, San Diego

Brief Summary:
This is a planning project with a clinical trial pilot to prepare for a larger fully powered clinical trial. Goals of this pilot project are: to identify and address any modifications of the games required for adaptation to diminished sensory abilities; to optimize training dosage and test timing of retention of effects; and to test and refine the battery of outcome assessments. Primary outcome assessment are tests of attention distraction (subtest from a Useful Field of View Test). This pilot will explore a number of secondary outcome measures including EEG and functional imaging biomarkers of change, measures of general cognitive improvement and measures of function including a driving simulator task.

Condition or disease Intervention/treatment Phase
Cognitive Enhancement Aging Behavioral: Gaze-driven training games Not Applicable

Detailed Description:
This is a planning trial to optimize procedures for a larger clinical trial. Participants will be randomized into one of two groups--an active group that has intervention training after initial visit and a wait control group that begins intervention after 12 weeks. All participants will receive in-lab baseline testing including IQ (WASI-II), a medical/psychiatric history questionnaire, a depression screen (Geriatric Depression Scale Short Form) and a pre-training battery that includes selected tests from the NIH toolbox, the Repeatable Battery for Neuropsychological Status (RBANS), a Useful Field of View task (UFOV), a driving simulator task, a dual (motor-cognitive) task, an n-back task with and without distractors(with EEG) and 6 minutes of resting state EEG. Participants will be trained to use the game system and play the game at the pre-training in-lab visit. Participants will be provided with a PC with eye-tracker that has training game software installed. Participants will play intervention training games at home for 8-12 weeks with in-lab assessments (the pre-training battery described above). Participants will be asked to play the training games a minimum of 5 times per week for 30 minutes at a time. Compliance will be monitored daily over a secure internet connection. If a participant has played less than the required time in a given week, a research associate will contact the participant to inquire about potential problems and to encourage the participant to resume or increase training time. The first group of 36 participants will receive post-training assessments at 8 weeks, 12 weeks and 6 months. The second group of 36 participants will have an additional pre-training session with structural and functional imaging and will receive only pre- and post-training assessment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Training Foundational Skills to Enhance Cognition in Older Adults
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Active Comparator: Active Intervention
Gaze-driven games, played at home on PC with eye-tracker, to train resistance to attention distraction and speed of processing.
Behavioral: Gaze-driven training games
Training games are played on a PC with attached eye-tracker. Games include embedded training principles to improve attentional control including resistance to distraction and inhibitory control.

No Intervention: Wait List Control
Wait list then cross over to active intervention.



Primary Outcome Measures :
  1. UFOV Attention Distraction [ Time Frame: 12 weeks ]
    Subtest from Useful Field of View Task

  2. UFOV Speed of Processing [ Time Frame: 12 weeks ]
    Subtest from Useful Field of View Task


Secondary Outcome Measures :
  1. Repeatable Battery for Neuropsychological Status (RBANS) [ Time Frame: 12 weeks ]
    Battery to assess general cognitive function



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. age 60-80 years old
  2. not demented
  3. living independently; and (4) fluent in English.

Exclusion Criteria:

  1. history of dementia, stroke, head injury involving loss of consciousness
  2. current psychiatric or neurological disorders other than depression/anxiety

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): NCT03900702


Contacts
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Contact: Anne M Engler, BA 8582461931 amengler@ucsd.edu
Contact: Sarah Hacker, BA 8582461931 shacker@ucsd.edu

Locations
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United States, California
Research on Autism and Development Lab, UCSD Recruiting
La Jolla, California, United States, 92122
Contact: Anne M Engler    858-246-1931    amengler@ucsd.edu   
Contact: Sarah Hacker    8582461931    shacker@ucsd.edu   
Sponsors and Collaborators
Jeanne Townsend, PhD
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Jeanne Townsend, PhD UCSD
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Responsible Party: Jeanne Townsend, PhD, Professor Emeritus, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03900702    
Other Study ID Numbers: U01AG062371 ( U.S. NIH Grant/Contract )
U01AG062371 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available by request to the PI 1 year following completion of study. Materials generated under the project will be disseminated in accordance with University/Participating institutional and NIH policies. Depending on such policies, materials may be transferred to others under the terms of a material transfer agreement. Access to databases and associated software tools generated under the project will be available for educational, research and non-profit purposes. Such access will be provided using web-based applications, as appropriate.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data available 1 year following study completion and for 5 years subsequently.
Access Criteria: Access for research or educational purposes, by application specifying use.

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