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

NYU Langone Health

Status: Enrolling

Conditions: Traumatic Brain Injury

Treatments: Behavioral: BrainHQ Cognitive Training Modules; Behavioral: BrainHQ People Skills Modules

Study type: Interventional

Funder types: Other

Identifiers

NCT04349852

20-00130

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

BrainHQ Cognitive Training Arm

Experimental group

Description:

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.

Treatment:

Behavioral: BrainHQ Cognitive Training Modules

BrainHQ People Skills Arm

Other group

Description:

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.

Treatment:

Behavioral: BrainHQ People Skills Modules