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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04349852
• Other study ID #: 20-00130
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: Gerald Voelbel, PhD
• Phone: 212-998-5827
• Email: gv23[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• 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. The BrainHQ will provide 3 training modules for the control group: 1) Recognition: a picture of a face is presented briefly and then the subject picks the recognized face from 3 pictures. 2) Face to Face: matching the emotional expression of 3 pictures to the emotional expression of the picture previously presented; 3) Face Facts: recalling 3 facts about a person that was previously presented. Participants will spend 45 minutes at each training session. 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in participants' visual memory after participating in BrainHQ 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.	baseline, 1 week post training, 4 weeks post training
Primary	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
Primary	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
Primary	Change in 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, 1 week post training, 4 weeks post training
Primary	Change in 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, 1 week post training, 4 weeks post training
Primary	Change in 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, 1 week post training, 4 weeks post training
Primary	Change in participants' level of reading	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.	baseline, 1 week post training, 4 weeks post training
Primary	Change in participants' spatial memory	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.	baseline, 1 week post training, 4 weeks post training
Primary	Change in participants' verbal memory	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.	baseline, 1 week post training, 4 weeks post training
Primary	Change in participants' ability to visually search	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.	baseline, 1 week post training, 4 weeks post training
Primary	Change in participants' ability to attention	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.	baseline, 1 week post training, 4 weeks post training
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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