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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

Tracking Information
First Submitted Date  ICMJE April 1, 2019
First Posted Date  ICMJE April 3, 2019
Last Update Posted Date April 3, 2019
Actual Study Start Date  ICMJE February 15, 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • UFOV Attention Distraction [ Time Frame: 12 weeks ]
    Subtest from Useful Field of View Task
  • UFOV Speed of Processing [ Time Frame: 12 weeks ]
    Subtest from Useful Field of View Task
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
Repeatable Battery for Neuropsychological Status (RBANS) [ Time Frame: 12 weeks ]
Battery to assess general cognitive function
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Training to Enhance Cognition in Older Adults
Official Title  ICMJE Training Foundational Skills to Enhance Cognition in Older Adults
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cognitive Enhancement
  • Aging
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Gaze-driven training games
  • No Intervention: Wait List Control
    Wait list then cross over to active intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Anne M Engler, BA 8582461931 amengler@ucsd.edu
Contact: Sarah Hacker, BA 8582461931 shacker@ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03900702
Other Study ID Numbers  ICMJE U01AG062371( U.S. NIH Grant/Contract )
U01AG062371 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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.
Responsible Party Jeanne Townsend, PhD, University of California, San Diego
Study Sponsor  ICMJE Jeanne Townsend, PhD
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Jeanne Townsend, PhD UCSD
PRS Account University of California, San Diego
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP