Traumatic Brain InjuryNCT04349852
Verbal Working Memory and Attention Remediation for Adults With Traumatic Brain Injury.
A study testing BrainHQ Cognitive Training Modules and BrainHQ People Skills Modules in people with Traumatic Brain Injury, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- BrainHQ Cognitive Training Modules and BrainHQ People Skills Modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
George Voelbel, PhD, 212-998-5827, gv23@nyu.edu
George Voelbel, Phd
About this study
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- BrainHQ Cognitive Training Modules, BrainHQ People Skills Modules
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainHQ Cognitive Training ModulesBehavioural
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 ModulesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BrainHQ Cognitive Training Arm | Experimental | BrainHQ Cognitive Training Arm Participants will be randomized into the BrainHQ Cognitive Training modules which are 35 minute training sessions. There will be 30 training sessions. Since the intervention is presented both visually and verbally through the computer, and participants will be asked if they have a quiet space and noise cancelling headphones. Participants will complete the training protocols remotely and their performance will be tracked. Participants will complete the 30 training sessions remotely, but will meet with the study team member online prior to beginning the exercises and right after completing the session. Receives: Behavioral: BrainHQ Cognitive Training Modules |
| BrainHQ People Skills Arm | Other | Participants will be randomized into the BrainHQ's Brain Game exercises which are 35 minute training sessions. There will be 30 training sessions. Since the intervention is presented both visually and verbally through the computer, and participants will be asked to complete the training in a quiet space and time to complete these activities. Participants will complete the 30 training sessions remotely, but will meet with the study team member online each training session prior to beginning the exercises and right after completing the exercises. Receives: Behavioral: BrainHQ People Skills Modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participants' logical memory after participating in BrainHQ 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.
Measured: baseline, 1 week post training, 4 weeks post training
Change in participants' verbal working memory after participating BrainHQ 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.
Measured: baseline, 1 week post training, 4 weeks post training
Change in participants' working memory after participating in BrainHQ 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.
Measured: baseline, 1 week post training, 4 weeks post training
Participants' vocabulary after participating in BrainHQ training
This will be measured by the Wechsler Adult Intelligence Scale IV, Vocabulary subtest which measure the ability to define specific words.
Measured: baseline
Participants' ability to recall information
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.
Measured: baseline
Participants' abstract reasoning
Measured by Wechsler Adult Intelligence Scale IV, Matrix Reasoning subtest which is a measure of abstract reasoning of visually presented stimuli.
Measured: baseline
Change in participants' level of reading
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.
Measured: baseline, 1 week post training, 4 weeks post training
Changes in the participants' processing speed
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.
Measured: baseline, 1 week post training, 4 weeks post training
Change in participants' verbal memory
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.
Measured: baseline, 1 week post training, 4 weeks post training
Change in participants ability to assess auditory information
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.
Measured: baseline, 1 week post training, 4 weeks post training
Change in participants' verbal attention.
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.
Measured: baseline, 1 week post training, 4 weeks post training
Change in participants' attention and verbal memory
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.
Measured: baseline, 1 week post training, 4 weeks post training
Changes to participants' ability to understand social cues
Awareness of Social Inference Test (TASIT)- Short version: is a standard measure to recognize emotions and a speaker's intentions presented in a vignette.
Measured: baseline, 1 week post training, 4 weeks post training
Change in participants' sense of depression
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.
Measured: baseline, 1 week post training, 4 weeks post training
Change in participants' sense of anxiety
Measured by self reports with the Beck's Anxiety Inventory which is a self-report instrument for the assessment of anxiety.
Measured: baseline, 1 week post training, 4 weeks post training
Changes to participants' mental status
Will be measured using the Lifetime Experience Questionnaire, \ a questionnaire to determine current and past mental.
Measured: baseline, 1 week post training, 4 weeks post training
Changes in participants' daily living
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.
Measured: baseline, 1 week post training, 4 weeks post training
Changes in the pattern of participants social lifestyle
This may be assessed with the Participation Assessment with Recombined Tools-Objective Questionnaire: A standardized questionnaire about social participation.
Measured: baseline, 1 week post training, 4 weeks post training
Changes in the participants' overall status
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.
Measured: baseline, 1 week post training, 4 weeks post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Aug 2021
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerald Voelbel, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349852
- Sponsor's protocol ID
- 20-00130
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2020
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verbal Working Memory and Attention Remediation for Adults With Traumatic Brain Injury.
- ClinicalTrials.gov ID
- NCT04349852
- Acronym / sponsor ID
- 20-00130
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BrainHQ Cognitive Training Arm | Experimental | Behavioral: BrainHQ Cognitive Training ModulesBrainHQ Cognitive Training Arm Participants will be randomized into the BrainHQ Cognitive Training modules which are 35 minute training sessions. There will be 30 training sessions. Since the intervention is presented both visually and verbally through the computer, and participants will be asked if they have a quiet space and noise cancelling headphones. Participants will complete the training protocols remotely and their performance will be tracked. Participants will complete the 30 training sessions remotely, but will meet with the study team member online prior to beginning the exercises and right after completing the session. |
| BrainHQ People Skills Arm | Other | Behavioral: BrainHQ People Skills ModulesParticipants will be randomized into the BrainHQ's Brain Game exercises which are 35 minute training sessions. There will be 30 training sessions. Since the intervention is presented both visually and verbally through the computer, and participants will be asked to complete the training in a quiet space and time to complete these activities. Participants will complete the 30 training sessions remotely, but will meet with the study team member online each training session prior to beginning the exercises and right after completing the exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainHQ Cognitive Training ModulesThe 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. | Behavioural | BrainHQ Cognitive Training Arm |
| BrainHQ People Skills ModulesThe 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. | Behavioural | BrainHQ People Skills Arm |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gerald Voelbel, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrainHQ Cognitive Training Modules and BrainHQ People Skills Modules in people with Traumatic Brain Injury, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerald Voelbel, PhD (212-998-5827, gv23@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participants' logical memory after participating in BrainHQ training (time frame: baseline, 1 week post training, 4 weeks post training). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.