Recruiting

Cognitive Remediation

Sponsor:

NYU Langone Health

Code:

NCT04349852

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BrainHQ Cognitive Training Modules

BrainHQ People Skills Modules

Study Details

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.

Conditions

Traumatic Brain Injury

Study ID

NCT04349852

Start date

Aug 1, 2021

Status verified date

Apr, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BrainHQ Cognitive Training Arm

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.

other: BrainHQ People Skills Arm

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.

Interventions

BrainHQ 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.

BrainHQ 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.

Primary outcome measure

  • Change in participants' logical memory after participating in BrainHQ training [ Time Frame: baseline, 1 week post training, 4 weeks post training ]
  • Change in participants' verbal working memory after participating BrainHQ training [ Time Frame: baseline, 1 week post training, 4 weeks post training ]
  • Change in participants' working memory after participating in BrainHQ training [ Time Frame: baseline, 1 week post training, 4 weeks post training ]
  • Participants' vocabulary after participating in BrainHQ training [ Time Frame: baseline ]
  • Participants' ability to recall information [ Time Frame: baseline ]
  • Participants' abstract reasoning [ Time Frame: baseline ]
  • Change in participants' level of reading [ Time Frame: baseline, 1 week post training, 4 weeks post training ]
  • Changes in the participants' processing speed [ Time Frame: baseline, 1 week post training, 4 weeks post training ]
  • Change in participants' verbal memory [ Time Frame: baseline, 1 week post training, 4 weeks post training ]
  • Change in participants ability to assess auditory information [ Time Frame: baseline, 1 week post training, 4 weeks post training ]
  • Change in participants' verbal attention. [ Time Frame: baseline, 1 week post training, 4 weeks post training ]
  • Change in participants' attention and verbal memory [ Time Frame: baseline, 1 week post training, 4 weeks post training ]
  • Changes to participants' ability to understand social cues [ Time Frame: baseline, 1 week post training, 4 weeks post training ]
  • Change in participants' sense of depression [ Time Frame: baseline, 1 week post training, 4 weeks post training ]
  • Change in participants' sense of anxiety [ Time Frame: baseline, 1 week post training, 4 weeks post training ]
  • Changes to participants' mental status [ Time Frame: baseline, 1 week post training, 4 weeks post training ]
  • Changes in participants' daily living [ Time Frame: baseline, 1 week post training, 4 weeks post training ]
  • Changes in the pattern of participants social lifestyle [ Time Frame: baseline, 1 week post training, 4 weeks post training ]
  • Changes in the participants' overall status [ Time Frame: baseline, 1 week post training, 4 weeks post training ]

Central Contacts and Locations

Central contacts

Gerald Voelbel, PhD

212-998-5827gv23@nyu.edu

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

George Voelbel, PhD

212-998-5827gv23@nyu.edu

Principal Investigator:

George Voelbel, Phd

More Information

Sponsor

NYU Langone Health

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-05-01.