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

Not Applicable

Recruiting

• Conditions: Traumatic Brain Injury
• Interventions: Behavioral: BrainHQ People Skills Modules; Behavioral: BrainHQ Cognitive Training Modules

• Registration Number: NCT04349852
• Lead Sponsor: NYU Langone Health

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 tasks of social awareness. 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 40 cognitive training modules, and 1-month post-completion of the first follow-up assessment.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-16
• Study Start: 2021-08-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2026-08-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 3 months post-injury.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BrainHQ People Skills Arm	BrainHQ People Skills Modules	Participants will be randomized into the BrainHQ People Skills Modules which are 45 minute training sessions. There will be 40 training sessions. Since the intervention is presented both visually and verbally through the computer, and participants will be asked tocomplete the training in a quiet space and time to complete these activities. Participants will complete the 40 training sessions remotely, but will meet with the study team member online prior to beginning the training and right after completing the training.
BrainHQ Cognitive Training Arm	BrainHQ Cognitive Training Modules	Participants will be randomized into the BrainHQ Cognitive Training modules which are 45 minute training sessions. There will be 40 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 40 training sessions remotely, but will meet with the study team member online prior to beginning the training and right after completing the training.

Primary Outcome Measures

Name	Time	Method
Change in participants' spatial memory	baseline, 1 week post training, 4 weeks post training	This will be assessed by the Spatial Span which is a measure of spatial working memory test. Participants are required to recall and tap the top of blocks in the same order they tapped by the administrator.
Change in participants' ability to visually search	baseline, 1 week post training, 4 weeks post training	This will be measured by using the Trails Making Test- A \& B which measures efficiency of visual search and set shifting while alternating between letters and numbers. The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.
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.
Change in participants' abstract reasoning	baseline, 1 week post training, 4 weeks post training	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	The will be measured by Wechsler Test of Adult Reading which is a measure that reliably estimates levels of intelligence by asking the subject to read aloud the words on an established reading list.
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' visual memory after participating in BrainHQ training	baseline, 1 week post training, 4 weeks post training	Measured by TOMM(Test of Memory Malingering) which is visual memory test that measures level of effort. Test of Memory Malingering is a 50-item visual recognition test designed to help distinguish malingering from genuine memory impairments.
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' vocabulary after participating in BrainHQ training	baseline, 1 week post training, 4 weeks post training	This will be measured by the Wechsler Adult Intelligence Scale IV, Vocabulary subtest which measure the ability to define specific words.
Change in participants' ability to recall information	baseline, 1 week post training, 4 weeks post training	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.
Change in participants' verbal memory	baseline, 1 week post training, 4 weeks post training	Measured by REY Auditory Learning Test (RAVLT). 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.
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' ability to attention	baseline, 1 week post training, 4 weeks post training	This will be measured with the Digit Cancellation Task. This is a timed test of attention that requires the participant to draw a slash through a targeted letter.
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.
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 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.
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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States