Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04349852

Verbal Working Memory and Attention Remediation for Adults With Traumatic Brain Injury.

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Location contact

George Voelbel, PhD

CONTACT

[email protected]

212-998-5827

George Voelbel, Phd

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BrainHQ Cognitive Training Modules

Behavioral

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.

BrainHQ People Skills Modules

Behavioral

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.

Primary outcomes

  1. Change in participants' logical memory after participating in BrainHQ training

    Time frame: 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.

  2. Change in participants' verbal working memory after participating BrainHQ training

    Time frame: 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.

  3. Change in participants' working memory after participating in BrainHQ training

    Time frame: 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.

  4. Participants' vocabulary after participating in BrainHQ training

    Time frame: baseline

    This will be measured by the Wechsler Adult Intelligence Scale IV, Vocabulary subtest which measure the ability to define specific words.

  5. Participants' ability to recall information

    Time frame: 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.

  6. Participants' abstract reasoning

    Time frame: baseline

    Measured by Wechsler Adult Intelligence Scale IV, Matrix Reasoning subtest which is a measure of abstract reasoning of visually presented stimuli.

  7. Change in participants' level of reading

    Time frame: 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.

  8. Changes in the participants' processing speed

    Time frame: 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.

  9. Change in participants' verbal memory

    Time frame: 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.

  10. Change in participants ability to assess auditory information

    Time frame: 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.

  11. Change in participants' verbal attention.

    Time frame: 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.

  12. Change in participants' attention and verbal memory

    Time frame: 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.

  13. Changes to participants' ability to understand social cues

    Time frame: 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.

  14. Change in participants' sense of depression

    Time frame: 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.

  15. Change in participants' sense of anxiety

    Time frame: 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.

  16. Changes to participants' mental status

    Time frame: 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.

  17. Changes in participants' daily living

    Time frame: 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.

  18. Changes in the pattern of participants social lifestyle

    Time frame: 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.

  19. Changes in the participants' overall status

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gerald Voelbel, PhD

CONTACT

[email protected]

212-998-5827

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2020
Registry last updated
May 1, 2026

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.

Published trials that share one or more normalized conditions with this study.