Traumatic Brain Injury
Conditions
Brief summary
This project will examine if computerized cognitive remediation will improve working memory and attention in 25 adults with a mild, moderate, or severe brain injury and compare their cognitive performance to the control group of 25 adults with a mild, moderate, or severe brain injury. The control group will train on computerized Brain Games. Participants in both groups will be assessed prior to training and immediately post-training and one month-post training.
Detailed description
The study design will be randomized assignment with a control group. Participants in both groups will undergo three cognitive assessments at baseline, at the end of 30 cognitive training modules, and 1-month post-completion of the first follow-up assessment.
Interventions
BEHAVIORALBrainHQ Cognitive Training Modules
The BrainHQ is a computerized training program developed from Posit Science designed to improve multiple cognitive domains. The subtests exercises include 6 modules for the experimental group: 1) Sound Sweeps: which is identify whether sound pitches are going up or down; 2) Memory Grids: matching pairs of words; 3) Syllable Stack: recognition of sequences of confusable syllables; 4) Fine Tuning: recognition of the order of confusable syllables; 5) To-Do List Training: reconstruction of sequences of verbal instructions; 6) In The Know: identification of details in a verbally presented story. Since the intervention is presented both visually and verbally through the computer, participants will be asked to complete their training in a quiet space and time to complete these activities.
BEHAVIORALBrainHQ People Skills Modules
The BrainHQ is a computerized training program developed from Posit Science designed to improve multiple cognitive domains. BrainHQ will provide 6 training modules for the control group: Crossword Puzzle - retrieve words according to the provided prompts. Lineup Four - Connect four colored discs so that they form a line in the horizontal, vertical or diagonal direction. Bricks Breaking Hex -Connect and remove bricks of the same color to clear the board. War Ship (Similar to Battleship)- place 5 vessels in the area at the left-hand side and sink enemy's hidden ships at the right-hand side by guessing enemy ship locations. Gem Swap - Form a line of 3 or more identical gems by swapping their positions. Sudoku - Fill each row, column, and 3x3 square with numbers 1 to 9 without repetition. Participants will spend 35 minutes at each training session. Participants will be asked to complete their training in a quiet space and time to complete these activities.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Medically documented mild, moderate, or severe TBI; * All subjects will be older than 18 years of age; * Free from schizophrenia or bipolar disorder, due to the potential influence of such disorders on cognitive functioning; * Free of current alcohol or drug abuse; * At least 12 months post-injury.
Exclusion criteria
* Younger than 18 years old. * A brain injury that is not medically documented. * Being diagnosed with schizophrenia or bipolar disorder. * Current alcohol or drug use diagnosis * Less than 3 months post-injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in participants' logical memory after participating in BrainHQ training | baseline, 1 week post training, 4 weeks post training | This will be measured by the Wechsler Memory Scale-IV (WMS-IV), Logical Memory subtest which is a measure of a person's ability to recall a story told to them. |
| Change in participants' verbal working memory after participating BrainHQ training | baseline, 1 week post training, 4 weeks post training | This will be measured by the Auditory Consonant Trigram (ACT), the ACT is a standard assessment measure used to evaluate working memory, attention, and cognitive interference. |
| Change in participants' working memory after participating in BrainHQ training | baseline, 1 week post training, 4 weeks post training | This will be measured by the Wechsler Memory Scale-IV (WMS-IV), Digit Span subtest which is a measure of working memory in which the person maintains their attention to the list of spoken numbers and ask to recall and state the list of numbers. |
| Participants' vocabulary after participating in BrainHQ training | baseline | This will be measured by the Wechsler Adult Intelligence Scale IV, Vocabulary subtest which measure the ability to define specific words. |
| Participants' ability to recall information | baseline | This will be measured by the Wechsler Adult Intelligence Scale IV, Information subtest which assesses the ability to recall general knowledge and acquired facts on different topics related to science, geography, and history. |
| Participants' abstract reasoning | baseline | Measured by Wechsler Adult Intelligence Scale IV, Matrix Reasoning subtest which is a measure of abstract reasoning of visually presented stimuli. |
| Change in participants' level of reading | baseline, 1 week post training, 4 weeks post training | This will be measured by Test of Premorbid Functioning which is a measure that reliably estimates levels of intelligence by asking the subject to read aloud the words on an established reading list. |
| Changes in the participants' processing speed | baseline, 1 week post training, 4 weeks post training | This will be measured by Digit Symbol Modality Test which is a is a standard assessment measure used to measure processing speed, working memory, attention, and executive functioning. The standardized oral version will be administered. |
| Change in participants' verbal memory | baseline, 1 week post training, 4 weeks post training | Measured by California Verbal Learning Test - II (CVLT). This test is a measure of verbal memory. A list of words is read aloud to the participants five times. After each list of words, the participant recalls the words. The participants will also be asked to recall the words from the list 20 minutes later. |
| Change in participants ability to assess auditory information | baseline, 1 week post training, 4 weeks post training | This will be assessed with the Paced Auditory Serial Addition Test (PASAT) - 3 \& 2 second versions which measures complex mental manipulation by adding the two most recent numbers that are presented auditorily. There are two sets of numbers that are presented at two different speeds. The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. |
| Change in participants' verbal attention. | baseline, 1 week post training, 4 weeks post training | Will be assessed with the Woodcock-Johnson - Understanding Directions subtest which is a measure of verbal attention. Participant are provided oral directions to point to different parts of pictures. |
| Change in participants' attention and verbal memory | baseline, 1 week post training, 4 weeks post training | Actual Reality Performance test is a measure of attention and verbal memory, which requires the participants to follow directions and sequence steps of computerized task. |
| Changes to participants' ability to understand social cues | baseline, 1 week post training, 4 weeks post training | Awareness of Social Inference Test (TASIT)- Short version: is a standard measure to recognize emotions and a speaker's intentions presented in a vignette. |
| Change in participants' sense of depression | baseline, 1 week post training, 4 weeks post training | This will be self reported using the Beck's Depression Inventory - II. This is a standardized instrument for the assessment of depression with a self-report questionnaire. |
| Change in participants' sense of anxiety | baseline, 1 week post training, 4 weeks post training | Measured by self reports with the Beck's Anxiety Inventory which is a self-report instrument for the assessment of anxiety. |
| Changes to participants' mental status | baseline, 1 week post training, 4 weeks post training | Will be measured using the Lifetime Experience Questionnaire, \\ a questionnaire to determine current and past mental. |
| Changes in participants' daily living | baseline, 1 week post training, 4 weeks post training | The Functional Behavior Profile Questionnaire will be used to measure daily living status. This is a standardized questionnaire regarding activities of daily living, executive functioning, participation, problems solving and social relationships. |
| Changes in the pattern of participants social lifestyle | baseline, 1 week post training, 4 weeks post training | This may be assessed with the Participation Assessment with Recombined Tools-Objective Questionnaire: A standardized questionnaire about social participation. |
| Changes in the participants' overall status | baseline, 1 week post training, 4 weeks post training | Will be gauged by using the Promis Global Health Questionnaire. This is a standardized questionnaire that evaluates physical, mental and social health deficits common in people with brain injuries. |
Countries
United States
Contacts
CONTACTGerald Voelbel, PhD
PRINCIPAL_INVESTIGATORGerald Voelbel, PhD
NYU Langone Health
Outcome results
None listed