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Completed

NCT Number: NCT03197454

Brain Enhancement Training Towards Elders Resilience to Aging

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.

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Key information

Conditions

Age-related Cognitive Decline

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa, Iowa City, Iowa, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Computerized plasticity-based adaptive cognitive training

Other

Forty-two minutes of training on computerized exercises that targets processing speed, memory and attention.

Commercially available computerized training

Other

Forty-two minutes of training on computerized, casual video games.

Primary outcomes

  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 outcomes

  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 memory

    Time frame: At 3 months and at 9 months

    Change in performance on memory will be measured using the composite score created by averaging the z-scores of Selective Reminding Task, Face Name Task, and Visual Short Term Memory tasks.

  3. 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, N-Back Task and Task Switch (fMRI task).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Posit Science Corporation

Industry

Collaborators

  • National Institute on Aging (NIA)
  • The University of Texas at Dallas
  • University of Iowa

Registry information

Official study title

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

Acronym: BETTER Aging

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 23, 2017
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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