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

Primary Purpose

Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BrainHQ Cognitive Training Modules
BrainHQ People Skills Modules
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Medically documented moderate to 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 mild traumatic brain injury (Concussion) or 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

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

BrainHQ Cognitive Training Arm

BrainHQ People Skills Arm

Arm Description

Participants will randomized into the BrainHQ Cognitive Training modules which are 45 minutes training sessions. There will be 40 training sessions. Since the intervention is presented both visually and verbally through the computer, noise cancelling head phones will also be provided to the participants. Participants will complete the training protocols in the lab under the study team's supervision to ensure the participants are engaged and are completing the tasks.

Participants will randomized into the BrainHQ People Skills Modules which are 45 minutes training sessions. There will be 40 training sessions. Since the intervention is presented both visually and verbally through the computer, noise cancelling head phones will also be provided to the participants. Participants will complete the training protocols in the lab under the study team's supervision to ensure the participants are engaged and are completing the tasks.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Changes to participants' mental status
Will be measured using the Lifetime Experience Questionnaire, \ a questionnaire to determine current and past mental.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 15, 2020
Last Updated
January 5, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT04349852
Brief Title
Verbal Working Memory and Attention Remediation for Adults With Traumatic Brain Injury.
Official Title
Verbal Working Memory and Attention Remediation for Adults With Traumatic Brain Injury.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project will examine if computerized cognitive remediation will improve working memory and attention in 25 adults with moderate to severe brain injury and compared their cognitive performance to the control group of 25 adults with moderate to 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BrainHQ Cognitive Training Arm
Arm Type
Experimental
Arm Description
Participants will randomized into the BrainHQ Cognitive Training modules which are 45 minutes training sessions. There will be 40 training sessions. Since the intervention is presented both visually and verbally through the computer, noise cancelling head phones will also be provided to the participants. Participants will complete the training protocols in the lab under the study team's supervision to ensure the participants are engaged and are completing the tasks.
Arm Title
BrainHQ People Skills Arm
Arm Type
Other
Arm Description
Participants will randomized into the BrainHQ People Skills Modules which are 45 minutes training sessions. There will be 40 training sessions. Since the intervention is presented both visually and verbally through the computer, noise cancelling head phones will also be provided to the participants. Participants will complete the training protocols in the lab under the study team's supervision to ensure the participants are engaged and are completing the tasks.
Intervention Type
Behavioral
Intervention Name(s)
BrainHQ Cognitive Training Modules
Intervention Description
The BrainHQ is a computerized training program developed from Posit Science designed to improve multiple cognitive domains. The subtests exercises include 3 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; and 3) Syllable Stack: recognition of sequences of confusable syllables. Since the intervention is presented both visually and verbally through the computer, noise cancelling head phones will also be provided to the participants.
Intervention Type
Behavioral
Intervention Name(s)
BrainHQ People Skills Modules
Intervention Description
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, noise cancelling head phones will also be provided to the participants.
Primary Outcome Measure Information:
Title
Change in participants' visual memory after participating in BrainHQ training
Description
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.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Change in participants' logical memory after participating in BrainHQ training
Description
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.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Change in participants' working memory after participating in BrainHQ training
Description
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.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Change in participants' vocabulary after participating in BrainHQ training
Description
This will be measured by the Wechsler Adult Intelligence Scale IV, Vocabulary subtest which measure the ability to define specific words.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Change in participants' ability to recall information
Description
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.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Change in participants' abstract reasoning
Description
Measured by Wechsler Adult Intelligence Scale IV, Matrix Reasoning subtest which is a measure of abstract reasoning of visually presented stimuli.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Change in participants' level of reading
Description
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.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Change in participants' spatial memory
Description
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.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Change in participants' verbal memory
Description
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.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Change in participants' ability to visually search
Description
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.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Change in participants' ability to attention
Description
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.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Change in participants ability to assess auditory information
Description
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.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Change in participants' verbal attention.
Description
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.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Change in participants' attention and verbal memory
Description
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.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Changes to participants' ability to understand social cues
Description
Awareness of Social Inference Test (TASIT)- Short version: is a standard measure to recognize emotions and a speaker's intentions presented in a vignette.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Change in participants' sense of depression
Description
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.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Change in participants' sense of anxiety
Description
Measured by self reports with the Beck's Anxiety Inventory which is a self-report instrument for the assessment of anxiety.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Changes to participants' mental status
Description
Will be measured using the Lifetime Experience Questionnaire, \ a questionnaire to determine current and past mental.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Changes in participants' daily living
Description
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.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Changes in the pattern of participants social lifestyle
Description
This may be assessed with the Participation Assessment with Recombined Tools-Objective Questionnaire: A standardized questionnaire about social participation.
Time Frame
baseline, 1 week post training, 4 weeks post training
Title
Changes in the participants' overall status
Description
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.
Time Frame
baseline, 1 week post training, 4 weeks post training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Medically documented moderate to 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 mild traumatic brain injury (Concussion) or 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerald Voelbel, PhD
Phone
212-998-5827
Email
gv23@nyu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Voelbel, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Voelbel, PhD
Phone
212-998-5827
Email
gv23@nyu.edu
First Name & Middle Initial & Last Name & Degree
George Voelbel, Phd

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing 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.
IPD Sharing 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.

Learn more about this trial

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

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