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

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ClinicalTrials.gov Identifier: NCT03197454
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : June 14, 2018
Sponsor:
Collaborators:
University of Iowa
The University of Texas at Dallas
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Posit Science Corporation

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

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.




Primary Outcome Measures :
  1. Global Cognitive Composite Score [ Time Frame: At 3 months and at 9 months ]
    Between-group magnitude of change in Global Cognitive Composite Score.


Secondary Outcome Measures :
  1. Processing Speed [ Time Frame: At 3 months and at 9 months ]
    Between-group magnitude of change in processing speed utilizing Pattern-Number Comparison, Letter-Number Comparison and Digit Symbol Substitution tasks.

  2. Changes in brain function [ Time Frame: At 3 months and at 9 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.

  3. Changes in brain structure [ Time Frame: At 3 months and at 9 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.

  4. Changes 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 of Visual Short Term Memory, Spatial Working Memory and N-Back Tasks.

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

  6. Changes 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 scores of Stroop Task and Task Switch.



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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 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 ideations as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)

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


Contacts
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Contact: Sarah-Jane Kim, MA 415-539-3130 sarah-jane.kim@positscience.com

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Chris Oehler       chris-oehler@uiowa.edu   
Principal Investigator: Michelle Voss, PhD         
United States, Texas
University of Texas at Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Nicholas Ray       nickray@utdallas.edu   
Principal Investigator: Chandramallika Basak, PhD         
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

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Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT03197454     History of Changes
Other Study ID Numbers: PSC-0605-17
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018

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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