Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 20 of 21

List	Outcome	Time frame	Description
Primary	Changes in performance on global cognitive composite score	At 3 months and at 6 months	Change in performance on global cognitive composite score based on the average of all normalized assessment measures.
Secondary	Changes in performance on processing speed composite score	At 3 months and at 6 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.
Secondary	Changes in performance on memory composite score	At 3 months and at 6 months	Change in performance on memory will be measured using the composite score created by averaging the z-scores of N-Back task, Spatial Working Memory task, WAIS-IV Digit Span and Rey Auditory Verbal Learning Test (RAVLT).
Secondary	Changes in performance on executive function composite score	At 3 months and at 6 months	Change in performance on executive function will be measured using the composite score created by averaging the z-scores for the Trail Making, Flanker, and Stroop tasks.
Secondary	Change in functional performance	At 3 months and at 6 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.
Secondary	Change in TBI functional status	At 3 months and at 6 months	Between-group magnitude of change in overall T-score using the self-report measure, Mayo-Portland Adaptability Inventory (MPAI-4). The overall T-score range is -38 to 106. Higher scores indicate more severe TBI functional status.
Secondary	Changes in brain function	At 3 months	Change in resting state functional connectivity will be measured by 12-minutes of resting state functional MRI. Participants will be instructed to keep their eyes open and maintain attention on a white fixation cross on a black screen.
Secondary	Changes in brain structure	At 3 months	Structural brain integrity will be measured with a high resolution 3D T1-weighted scan with good gray/white matter contrast and a complementary high-resolution T2-weighted anatomical scan.
Secondary	Changes in task-related brain activation	At 3 months	Change in functional connectivity and brain activation will be measured while performing N-Back Task.
Other	Change in Neurobehavioral Symptoms	At 3 months and at 6 months	Between-group magnitude of change in sum score using the self-report measure, Neurobehavioral Symptoms Index (NSI). The scoring range is 0-88. Higher scores indicate more severe neurobehavioral symptoms.
Other	Change in PTSD Symptoms	At 3 months and at 6 months	Between-group magnitude of change in sum score using the self-report measure, PTSD Checklist (PCL-5). The scoring range is 0-80. Higher scores indicate more severe PTSD symptoms
Other	Change in Depressive Symptoms	At 3 months and at 6 months	Between-group magnitude of change in sum score using the self-report measure, Beck Depression Inventory (BDI-II). The scoring range is 0-63. Higher scores indicate more severe depressive symptoms.
Other	Change in Health-Related Quality of Life	At 3 months and at 6 months	Between-group magnitude of change in sum score using the self-report measure, Quality of Life after Brain Injury (QOLIBRI). The scoring range is 0-100. Lower scores indicate lower quality of life.
Other	Change in Executive Function Symptoms	At 3 months and at 6 months	Between-group magnitude of change in After total T-score using the self-report measure, Frontal Systems Behavior Scale (FrSBe). Raw scores are converted to age- and education-corrected T-scores. The mean T-score is 50, scores greater than 65 are considered clinically significant.
Other	Change in Cognitive Symptoms	At 3 months and at 6 months	Between-group magnitude of change in sum score using the self-report measure, Cognitive Failures Questionnaire (CFQ). The scoring range is 0-100. Higher scores indicate more severe cognitive symptoms.
Other	Change in Work/School Status	At 3 months and at 6 months	Change in total score using the self-report questionnaire about their work/school status.
Other	Change in Physical Activity	At 3 months	Change in total score based on weekly self-report dairy about physical activity during training period.
Other	Change in Diet	At 3 months	Change in total score based on weekly self-report dairy about diet during training period.
Other	Change in Social Activity	At 3 months	Change in total score based on weekly self-report dairy about social activity during training period.
Other	Change in Sleep	At 3 months	Change in total score based on weekly self-report dairy about sleep during training period.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Registered outcomes21

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