Clinical trial NCT04349852: 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
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 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.

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 3 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

Primary outcomes:
measure: Change in participants' visual memory after participating in BrainHQ training
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Change in participants' logical memory after participating in BrainHQ training
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Change in participants' working memory after participating in BrainHQ training
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Change in participants' vocabulary after participating in BrainHQ training
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Change in participants' ability to recall information
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Change in participants' abstract reasoning
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Change in participants' level of reading
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Change in participants' spatial memory
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Change in participants' verbal memory
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Change in participants' ability to visually search
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Change in participants' ability to attention
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Change in participants ability to assess auditory information
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Change in participants' verbal attention.
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Change in participants' attention and verbal memory
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Changes to participants' ability to understand social cues
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Change in participants' sense of depression
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Change in participants' sense of anxiety
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Changes to participants' mental status
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Changes in participants' daily living
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Changes in the pattern of participants social lifestyle
timeFrame: baseline, 1 week post training, 4 weeks post training
measure: Changes in the participants' overall status
timeFrame: baseline, 1 week post training, 4 weeks post training
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Gerald Voelbel, PhD
role: PRINCIPAL_INVESTIGATOR
References: