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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week post training, 4 weeks post training
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in participants ability to assess auditory information
Change in participants' ability to attention
Change in participants' ability to recall information
+18 more

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.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,517 Total Patients Enrolled
Gerald Voelbel, PhDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
11 Total Patients Enrolled

Media Library

BrainHQ Cognitive Training Modules Clinical Trial Eligibility Overview. Trial Name: NCT04349852 — N/A
Traumatic Brain Injury Research Study Groups: BrainHQ Cognitive Training Arm, BrainHQ People Skills Arm
Traumatic Brain Injury Clinical Trial 2023: BrainHQ Cognitive Training Modules Highlights & Side Effects. Trial Name: NCT04349852 — N/A
BrainHQ Cognitive Training Modules 2023 Treatment Timeline for Medical Study. Trial Name: NCT04349852 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any participants still being admitted to this research endeavor?

"Clinicaltrials.gov indicates that this research is still open to participants, with the experiment first being publicly posted in August 2021 and last updated at the end of February 2022."

Answered by AI

Does this trial have an age restriction? Can those younger than 50 years be enrolled?

"Patients must be between 18 and 100 years old to qualify for inclusion in this trial. An additional 156 trials exist where those under the age of 18 can participate, while 702 are available specifically for individuals over 65."

Answered by AI

What is the capacity of participants in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this research project still requires 50 participants from a single medical centre and was first posted on August 1st 2021 before its most recent update on February 28th 2022."

Answered by AI

What criteria must potential participants satisfy for eligibility in this research project?

"To qualify for this research, applicants must possess some form of neurological damage and be aged between 18-100 years. The investigators are currently in search of 50 participants."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Verbal Working Memory and Attention Remediation for Adults With Traumatic Brain Injury.
2021. "Verbal Working Memory and Attention Remediation for Adults With Traumatic Brain Injury.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04349852.
All > Memory > Traumatic Brain Injury
~4 spots leftby Aug 2024
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