Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT06130735
To investigate factors that predict cognitive enhancement following engagement in an intensive Computerized Cognitive Training Protocol.
This study is active but is not currently recruiting participants.
25 year–65 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
To investigate factors that predict cognitive enhancement following engagement in an intensive 6-month, 5 days per week training use the ABI Wellness BEARS platform and Brainex Software Symbol Relations Module.
The study will examine the impact of intensive working memory training on neurocognitive markers of brain plasticity (intervention-related changes) in 1) performance on neuropsychological tests, 2) BDNF levels in blood and salivary, 3) ERP measures of working memory, and 4) resting state fMRI and structural MRI.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will log into ABI Wellness Platform five days per week (M-T-W-Th-F) and train using the Symbol Relations module for 45 to 60 minutes. Every other week, participants will meet with their training facilitator via zoom to review training progress and troubleshoot any training-related questions.
Time frame: 6 months
We will use age-corrected standard scores of the NIH toolbox Total Cognitive Composite, Fluid Intelligence Composite, and individual scores on RAVLT, Verbal Fluency, and Trailmaking Task as cognitive outcome measures.
Time frame: 6 months
Using FUJIFILM high sensitivity ELISA kits and commercially available ELISA kits.
Time frame: 6 months
Physical Activity Scale for the Elderly (questionnaire).
Measures walking, moderate, and vigorous activity. Zero lower limit, no upper limit. Higher values indicate more physical activity.
Time frame: 6 months
Time frame: 6 months
A group ICA analysis procedure will be applied to pre- and post-intervention rs-fMRI BOLD signal activity. Correlations will be explored between fMRI parameters, cognitive, and training data (e.g NIH toolbox Total Cognitive Composite, Fluid Intelligence Composite, Crystallized Composite, CCT engagement and progress).
Time frame: 6 months
Flanagan Quality of Life Scale (questionnaire).
Measures quality of life. Likert scale 0-112, higher values indicate higher quality of life.
Time frame: 6 months
Medical Outcomes Study Sleep Scale (questionnaire)
Likert scale measuring sleep quality and sleep problems index. 0-60 with greater values representing higher sleep quality and lower sleep problems.
Time frame: 6 months
Generalized Anxiety Disorder 7 Item Scale (questionnaire)
Likert scale measuring severity of anxiety. 0-21 with greater values representing more severe anxiety.
Time frame: 6 months
Patient Health Questionnaire Depression Scale (questionnaire)
Likert scale measuring the severity of depression. 0-24 with higher scores representing more severe depression.
Time frame: 6 months
Modified Fatigue Impact Scale
Likert scale on the impact of fatigue on one's physical, cognitive, and psychosocial activity. 0-84 with higher scores indicating a greater impact of fatigue on a person's activities.
Time frame: 6 months
Cognitive Self- Efficacy Questionnaire
Likert scale on feelings people have about their cognition/thinking skills. 0-72 with a higher score indicating more positive feelings regarding the efficacy of ones cognitive/thinking abilities.
Brigham and Women's Hospital
Other
Computerized Cognitive Training: Characterization of Factors That Predict Cognitive Enhancement in Acquired Brain Injury
Acronym: CCT
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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