About this trial
The proposed study tests the efficacy (Phase II) of 36 or 54 30-minute training sessions of PATH neurotraining followed by digit memory exercises to improve working memory, processing speed and attention in mTBI patients rapidly and effectively to provide clinical testing of a therapeutic training for the remediation of cognitive disorders caused by a concussion. This study will contribute to the fundamental knowledge of how to remediate concussions from a mTBI to enhance the health, lengthen the life and reduce the disabilities that result from a mTBI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Referred by Clinician verifying that patient has an mTBI (also includes moderate TBI: those who had a severe TBI with a loss of consciousness more than 30 minutes that is now an mTBI) and has a visual working memory loss as determined by first neuropsychological pre-test administered: The Test of Information Processing Skills (TIPS),
One or more concussions,
Any loss of consciousness from 5- 30 min (not longer than 30 min) to be in mTBI group, otherwise in moderate TBI group.
Any loss of memory for events immediately before or after the accident for 24 hours is in mTBI group, otherwise is in moderate TBI group,
Disqualifiers
mTBI occurred less than 3 months earlier [While post-concussive symptoms (PCS) resolve within days post injury in the majority of individuals with mTBI,127 symptoms can endure 3 months post injury or longer, indicating spontaneous recovery and chronic sequela.128 In the general public, between 8% to 33% of mTBI patients have persistent PCS and long-term cognitive and/or behavioral impairments129 that negatively impact quality of life. In the proposed study, we will try to minimize the confound from the spontaneous recovery by only recruiting chronic mTBI subjects, and not recruiting mTBI subjects with mTBI less than 3 months.] with no maximum time if still experiencing memory problems which will be measured by the TIPS visual working memory (VWM) scores.
diagnosis of epilepsy or seizure disorder in last 12 months,
diagnosis of moderate depressive disorder or moderate anxiety, having driving limitations in traffic
answers 'Yes' to any of the questions on the Columbia Suicide Severity Rating Scale,
Trial design
Parallel
Treatments tested in this trial
PATH + DigitMemory (DM) neurotraining
BehavioralImprove visual timing and sensitivity in the dorsal stream. The mTBI subject will sit 57 cm in front of a computer monitor. During the presentation, the bars in the 'fish-shaped' window in the center of the screen formed by a sinusoidal grating, move left or right very briefly. When the screen goes blank, the subject reports which way the center pattern moved by pushing the left or right arrow key. A brief tone is presented after incorrect responses. The program adaptively changes the contrast of the test pattern so that the subject detects motion at lowest contrast possible. A sequence of patterns in each training cycle that are designed to optimally activate magnocellular neurons are shown to the subject. There are two programs, the first measures the contrast needed to see one direction of movement, and the second program measures the contrast needed to see two directions of movement, requiring memory. Both are followed by digit memory exercises.
Treatment groups
Trial outcomes
Primary outcomes
Change in Visual Working Memory
Visual Working Memory (VWM) using Test of Information Processing Skills (TIPS), having two distractor tasks to measure Sequential Processing: the subject must remember a sequence of letters, that are shown one at a time for 2 seconds each, for sequences of from 2 up to 9 letters right after seeing the entire sequence of letters. Short Term that are shown one at a time for 2 seconds each, for sequences of from 2 up to 9 letters right after seeing the entire sequence of letters. Short Term VWM is assessed by recalling the correct sequence of letters after counting from 1 to 10 numbers in sequence, starting at different initial numbers, slowly, and after repeating a short sentence with an animal subject for VWM. Delayed Recall is assessed by remembering all animal names in repeated sentences 3 minutes after finish the VWM tests. The TIPS VWM Standardized Percentile Rank goes from \<1% to 99%.
Secondary outcomes
Change in Processing Speed
Processing Speed using Wechsler Adult Intelligence Scale (WAIS-4) Processing Speed Index (PSI): requires two subtests: 1) the WAIS Symbol Search subtest which requires subjects to scan a target group (two symbols) and search a group of 5 symbols, indicating whether one of the target symbols appears in the search group, and 2) WAIS Digit Symbol Coding subtest, where the subject fills in boxes below digits with symbols that are paired with them in a key at the top of the page. Both of these subtests are timed for two minutes each. The scaled scores from each subtest are combined to create an overall Processing Speed Index score, that is converted to a standardized percentile. WAIS Processing Speed Index Standardized Percentile Rank goes from \< 0.1% to \> 99%.
Change in Attentional Focus
Selective Attention using Delis-Kaplan Executive Function System (DKEFS) Color-Word Interference test measuring time to say color of the printed word that denotes a different color (Stroop test). DKEFS Color-Word Interference Test Standardized Percentile Rank for Inhibition subtest goes from 0.5% to 99.9%.
Change in Cognitive Flexibility
Cognitive Flexibility using DKEFS Color-Word Interference test measuring time to switch attention between color of printed word (Stroop test) and printed word when surrounded by a rectangle. DKEFS Color-Word Interference Test standardized scores for Standardized Percentile Rank for Inhibition Switching subtest goes from 0.5% to 99.9%.
Change in Auditory Working Memory
Auditory Working Memory (AWM) is assessed using the WAIS-4 Working Memory Index which consists of two subtests: 1) the Digit Span subtest, where the subject has to repeat a list of spoken numbers, requiring the subject to remember subsequently more numbers: in the correct order, backwards, and in numerical sequence on three different subtests, and 2) the Letter-Number Sequencing subtest which requires sequencing subsequently more numbers and letters in the correct numerical and alphabetic sequence. Presentation of the numbers and letters are timed for one second each for these working memory tests. The WAIS Working Memory Index Standardized Percentile Rank goes from \< 0.1% to \> 99.9%.
Sponsors and contacts
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Perception Dynamics Institute
Lead sponsor
University of California, San Diego
Collaborator