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Cognitive Training for Traumatic Brain Injury

N/A

Recruiting

Led By Gerald Voelbel, PhD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All subjects will be older than 18 years of age

Medically documented mild, moderate, or severe TBI

Must not have

Younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 week post training, 4 weeks post training

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether computerized cognitive training can improve working memory and attention in people with brain injuries, compared to a control group who will receive training in social awareness. There will be follow-up assessments of both groups after the training program.

Who is the study for?

This trial is for adults over 18 with a medically documented mild, moderate, or severe traumatic brain injury (TBI) who are at least three months post-injury. It excludes those with schizophrenia, bipolar disorder, or current alcohol/drug abuse to avoid cognitive performance interference.

What is being tested?

The study tests if computerized cognitive remediation can improve working memory and attention in TBI patients. It involves BrainHQ Cognitive Training Modules compared to social awareness tasks in a control group. Assessments occur before training, immediately after, and one month later.

What are the potential side effects?

Since the interventions involve non-invasive computerized training modules focused on cognition and social skills, there are no direct medical side effects expected from participation in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I have a medically confirmed traumatic brain injury.

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I do not have schizophrenia or bipolar disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 week post training, 4 weeks post training

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 week post training, 4 weeks post training

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week post training, 4 weeks post training for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in participants ability to assess auditory information

Change in participants' ability to attention

Change in participants' ability to recall information

+18 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: BrainHQ People Skills ArmExperimental Treatment1 Intervention

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.

Group II: BrainHQ Cognitive Training ArmExperimental Treatment1 Intervention

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.

0 / 4Eligibility criteria met