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
|Condition or disease||Intervention/treatment||Phase|
|Age-related Cognitive Decline||Other: Computerized Plasticity-Based Adaptive Cognitive Training Other: Commercially available computerized training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- Global Cognitive Composite Score [ Time Frame: At 3 months and at 9 months ]Between-group magnitude of change in Global Cognitive Composite Score.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Sarah-Jane Kim, MAemail@example.com|
|United States, Iowa|
|University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Chris Oehler firstname.lastname@example.org|
|Principal Investigator: Michelle Voss, PhD|
|United States, Texas|
|University of Texas at Dallas||Recruiting|
|Dallas, Texas, United States, 75235|
|Contact: Nicholas Ray email@example.com|
|Principal Investigator: Chandramallika Basak, PhD|
|Principal Investigator:||Hyun Kyu Lee, PhD||Posit Science Corporation|