Rehabilitation of Visual Attention Following mTBI

Traumatic Brain Injury Clinical Trial

Official title:

Rehabilitation of Visual Attention Following mTBI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02719964
• Other study ID #: NMCSD.2015.0049
• Status: Recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: October 2020

Study information

• Verified date: March 2019
• Source: United States Naval Medical Center, San Diego
• Contact: Angelica Dilay, MPH
• Email: angelica.n.dilay.ctr[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this proposal is to evaluate the effectiveness of rehabilitation for visual attention deficits in U.S. military service members across three programs: Visual Attention and Working Memory Programs (UCR Games), Speech Pathologist-Directed Treatment, and General Cognitive Rehabilitation Games (Lumosity).

In addition to the above prospective component, this study also has a retrospective component in which archival data collected from routine clinical care will be examined for analysis. The investigators hope to gain a better understanding of the unique and cumulative influence different cognitive rehabilitation programs have on improving attention complaints in mTBI.

Description:

Mild traumatic brain injury (mTBI) is one of the most commonly sustained combat-related injuries. Complaints of poor attention often follow mTBI and can become chronic in some individuals. Chronic attention complaints have traditionally been treated with cognitive rehabilitation by speech pathologists. Recent research has shown that computerized programs may add additional value either independently or in conjunction with traditional therapies. Researchers at UC Riverside have already completed research showing that vision training, using the ULTIMEYES program that they created, led to improved vision both on standard assessments, such as reading eye-charts, and in real world skills, such as reading and playing baseball. This program is designed to broadly improve basic aspects of vision, such as visual acuity and contrast sensitivity, as well as high-level vision, such as attention. Furthermore, an associated memory training task (Recall The Game) shows improvements in memory tasks and transfer to skills such as fluid intelligence.

The objective of this proposal is to evaluate the effectiveness of rehabilitation for visual attention deficits in U.S. military service members across three programs:

1. Visual Attention and Memory Program (UCR Games)

2. Cognitive and Psychological Based Rehabilitation (Speech Pathologist-Directed Therapy)

3. General Cognitive Rehabilitation Games (Lumosity [2])

The investigators hope to gain a better understanding of the unique and cumulative influence of different cognitive rehabilitation programs on improving attention complaints in mTBI. This proposal contains both retrospective and prospective components.

The retrospective component consists of examining archival data from Lumosity, previously collected as part of routine clinical care. The data contain pre- and post-assessments of post-concussive symptoms, symptom frequency, and cognitive testing. The investigators expect that data analysis will reveal evidence of improvement in severity of post-concussive symptoms, in frequency of troublesome cognitive problems, and in performance on neuropsychological tests when pre- and post-assessments are compared.

The prospective component will consist of 120 service members with mTBI who have ongoing attention complaints and are more than three months post-injury. Each service member will be randomly assigned to one of four arms, differentiated only by the specific computer-based rehabilitation program used. All individuals will also be treated per current standard of care guidelines by a speech pathologist.

Each of the four arms will be comprised of 30 participants. A cognitive testing battery will be administered to each participant before and after implementation of each intervention. The cognitive testing battery form will vary based on time of administration in order to control for practice effects. Performance on the cognitive testing battery and self-report measures will be compared between and within the three arms.

This research will help the military to identify the best cognitive rehabilitation treatment program to address ongoing attention complaints following mTBI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Closed TBI

• Have sufficient information available that we can confidently classify severity as mild based on DOD/VA criteria

• Time tested post-injury > 3 months

• Ongoing attention complaints

Exclusion Criteria:

• Moderate/Severe TBI

• Penetrating TBI

• Attention Deficit Hyperactivity Disorder

• Learning Disorder

• Diagnosed medical condition that is expected to impact cognitive performance (i.e. Multiple Sclerosis, Stroke)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Other:
• Visual Attention Program (UCR Games)
This program is an individual-directed computerized cognitive rehabilitation program based on perceptual learning approaches to enhance visual attention. Training incorporates a diverse set of stimuli, optimized stimulus presentation, multisensory facilitation, and consistently reinforcing training stimuli. This will be completed in a group setting with an instructor available to facilitate questions.
• Speech Pathologist-Directed Therapy
This is a speech pathologist-directed arm and will provide a traditional clinician-directed individualized cognitive rehabilitation program. Cognitive treatment is a systematic, functionally oriented program of therapeutic activities that focuses on strengthening previously learned patterns of behavior, establishing new patterns through use of internal and external compensatory cognitive strategies, and enabling the individual to adapt to the changes in his or her revised approaches to cognitive functioning. Increased performance success is reinforced through repetition, errorless learning, and gradually increasing task stimuli and complexity in a structured systematic approach.
• General Cognitive Rehabilitation Games (Lumosity)
Lumosity is a commercially available computerized program purported to enhance cognitive functioning through a variety of computerized programs that utilize various cognitive abilities.

Locations

Country	Name	City	State
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

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* Note: There are 83 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-Concussion Cognitive Symptoms	Comparison of performance on pre- and post-intervention neuropsychological testing battery.	Two Months
Primary	Severity of Post-Concussive Symptoms	Comparison of self-reported symptoms on pre- and post-intervention assessment.	Two Months