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Recruiting NCT04349852

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

No phase Interventional Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BrainHQ Cognitive Training Modules, BrainHQ People Skills Modules.
Who it may be relevant to
Registry conditions: Traumatic Brain Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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 30 cognitive training modules, and 1-month post-completion of the first follow-up assessment.

Interventions

  • 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
  • Behavioral 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

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT04349852 · 20-00130

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗