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

NCT04349852 | Recruiting DMC

• 1 other identifier: 20-00130
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (19)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  baseline, 1 week post training, 4 weeks post training

Study Arms (2)

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.

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.

Behavioral: BrainHQ People Skills Modules

Interventions

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 Cognitive Training Arm

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.

BrainHQ People Skills Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Gerald Voelbel, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerald Voelbel, PhD

CONTACT

212-998-5827; gv23@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 16, 2020
• Study Start: August 1, 2021
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to gv23@nyu.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)