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Brain Enhancement Training Towards Elders Resilience to Aging (BETTER Aging)

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ClinicalTrials.gov Identifier: NCT03197454
Recruitment Status : Completed
First Posted : June 23, 2017
Last Update Posted : October 17, 2022
Sponsor:
Collaborators:
University of Iowa
The University of Texas at Dallas
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Posit Science Corporation

Study Description
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Brief Summary:
This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.

Condition or disease Intervention/treatment Phase
Age-related Cognitive Decline Other: Computerized Plasticity-Based Adaptive Cognitive Training Other: Commercially available computerized training Not Applicable

Detailed Description:
The primary objective of this study is to evaluate the effects of the experimental treatment (cognitive training) further outlined in this protocol on the cognitive abilities (e.g., processing speed, attention, working memory, and executive function), brain functionality, functional status and quality of life of individuals with age-related cognitive decline as compared to a computer-based active control.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brain Enhancement Training Towards Elders Resilience to Aging (BETTER Aging)
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : July 16, 2021
Actual Study Completion Date : July 16, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Treatment
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.
 Other: Computerized Plasticity-Based Adaptive Cognitive Training
Forty-two minutes of training on computerized exercises that targets processing speed, memory and attention.
Active Comparator: Active Comparator
Commercially available computerized training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.
 Other: Commercially available computerized training
Forty-two minutes of training on computerized, casual video games.


Outcome Measures
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Primary Outcome Measures :
  1. Change in performance on global cognitive composite score [ Time Frame: At 3 months and at 9 months ]
    Change in performance on global cognitive composite score based on the average of all normalized assessment measures.


Secondary Outcome Measures :
  1. Change in performance on processing speed composite score [ Time Frame: At 3 months and at 9 months ]
    Change in performance on processing speed will be measured using the composite score created by averaging the z-scores of Pattern Comparison, Letter Comparison, and Digit Symbol Coding tasks.

  2. Change in performance on working memory [ Time Frame: At 3 months and at 9 months ]
    Change in performance on working memory will be measured using the composite score created by averaging the z-scores of Visual Short Term Memory and N-Back Tasks.

  3. Changes in performance on episodic memory [ Time Frame: At 3 months and at 9 months ]
    Change in performance on episodic memory will be measured using the composite score created by averaging the z-scores of Selective Reminding Task and Face Name Task.

  4. Change in performance on executive function [ Time Frame: At 3 months and at 9 months ]
    Change in performance on executive function will be measured using the composite score created by averaging the z-scores of Flanker Task and Task Switch (fMRI task).

  5. Change in brain function [ Time Frame: At 3 months ]
    Change in resting state functional connectivity will be measured by resting State T2*weighted EPI-BOLD, a 10-minute task-free BOLD contrast sequence consisting of 300 volumes (TR=2000 ms/TE=30ms) at 3.4mm3 in-plane resolution and 3mm slice thickness. Participants will be instructed to keep their eyes open and maintain attention on a central gray fixation cross on a black screen.

  6. Change in brain structure [ Time Frame: At 3 months ]
    3D T1-Weighted multi-echo MPRAGE. Morphometric analyses will be based on this MRI sequence (not accelerated because the reliability of acceleration for multi-site studies has not yet been established). We will achieve spatial resolution of 1 x 1 x 1 mm voxels.

  7. Change in task-related brain activation [ Time Frame: At 3 months ]
    Change in functional connectivity and brain activation will be measured while performing Task Switch.

  8. Change in functional performance [ Time Frame: At 3 months and at 9 months ]
    Between-group magnitude of change in sum time of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance.

  9. Change in Depressive Symptoms [ Time Frame: At 3 months and at 9 months ]
    Between-group magnitude of change in sum score using the self-report measure, Center for Epidemiologic Studies Depression Scale (CES-D). The scoring range is 0-60. Higher scores indicate the presence of more symptomatology.


Other Outcome Measures:
  1. Change in Stress [ Time Frame: At 3 months and at 9 months ]
    Between-group magnitude of change in sum score using the self-report measure, Perceived Stress Scale (PSS-10). The scoring range is 0-40. Higher scores indicate higher perceived stress.

  2. Change in Self-Efficacy [ Time Frame: At 3 months and at 9 months ]
    Between-group magnitude of change in sum score using the self-report measure, Self-Efficacy Survey. The scoring range is 10-40. Lower scores indicate lower self efficacy.

  3. Change in Life Satisfaction [ Time Frame: At 3 months and at 9 months ]
    Between-group magnitude of change in sum score using the self-report measure, Life Satisfaction Scale. The scoring range is 5-35. Lower scores indicate lower life satisfaction.

  4. Change in Physical Activity [ Time Frame: At 3 months ]
    Change in total score based on weekly self-report dairy about physical activity during training period.

  5. Change in Diet [ Time Frame: At 3 months ]
    Change in total score based on weekly self-report dairy about diet during training period.

  6. Change in Social Activity [ Time Frame: At 3 months ]
    Change in total score based on weekly self-report dairy about social activity during training period.

  7. Change in Sleep [ Time Frame: At 3 months ]
    Change in total score based on weekly self-report dairy about sleep during training period.

  8. Change in Functional Abilities [ Time Frame: At 3 months ]
    Change in total score based on weekly self-report dairy about functional abilities during training period.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant must be 65 years of age or older
  • Participant must be a fluent English speaker
  • Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse
  • Participant must not have evidence of dementia as indicated by the Montreal Cognitive Assessment (MoCA)

Exclusion Criteria:

  • Participant with any medical illnesses, injuries or conditions predisposing to imminent functional and/or cognitive decline
  • Participant requiring caregiver assistance in dressing/personal hygiene
  • Participant with severe visual deficits (including visual neglect, partial field cuts, anopias) and/or severe hearing deficit that would prevent use of the computerized treatment program
  • Participant with recent participation of computer-delivered cognitive training within 2 years of consent
  • Participant with claustrophobia or any other contraindication to MRI scanning
  • Participant with inability to complete a 1-hour MRI
  • Pregnant women
  • Participant with any implanted devices above the waist (e.g., cardiac pacemaker or auto-defibrillators, neural pacemaker, aneurysm clips, cochlear implant, metallic bodies in the eye or central nervous system, any form of wires or metal devices that may concentrate radio frequency fields)
  • Participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Contacts and Locations
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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): NCT03197454


Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Texas
University of Texas at Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Posit Science Corporation
University of Iowa
The University of Texas at Dallas
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Hyun Kyu Lee, PhD Posit Science Corporation
More Information
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Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT03197454    
Other Study ID Numbers: PSC-0605-17
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: October 17, 2022
Last Verified: October 2022

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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