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Rehabilitation of Visual Attention Following mTBI

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ClinicalTrials.gov Identifier: NCT02719964
Recruitment Status : Recruiting
First Posted : March 25, 2016
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
United States Naval Medical Center, San Diego

Brief 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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Other: Visual Attention Program (UCR Games) Other: Speech Pathologist-Directed Therapy Other: General Cognitive Rehabilitation Games (Lumosity) Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Rehabilitation of Visual Attention Following mTBI
Study Start Date : May 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: A: UCR Games→SP-Directed Therapy
Participants in Arm A will first participate in Visual Attention Program (UCR Games) followed by Speech Pathologist-Directed Therapy with assessment sessions prior to and following each treatment 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.

Other: 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.

Experimental: B: Lumosity→SP-Directed Therapy
Participants in Arm B will first participate in General Cognitive Rehabilitation Games (Lumosity) followed by Speech Pathologist-Directed Therapy with assessment sessions prior to and following each treatment intervention.
Other: 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.

Other: 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.

Experimental: C: SP-Directed Therapy→UCR Games
Participants in Arm C will first participate in Speech Pathologist-Directed Therapy followed by Visual Attention Program (UCR Games) with assessment sessions prior to and following each treatment 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.

Other: 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.

Experimental: D: SP-Directed Therapy→Lumosity
Participants in Arm D will first participate in Speech Pathologist-Directed Therapy followed by General Cognitive Rehabilitation Games (Lumosity) with assessment sessions prior to and following each treatment intervention.
Other: 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.

Other: 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.




Primary Outcome Measures :
  1. Post-Concussion Cognitive Symptoms [ Time Frame: Two Months ]
    Comparison of performance on pre- and post-intervention neuropsychological testing battery.

  2. Severity of Post-Concussive Symptoms [ Time Frame: Two Months ]
    Comparison of self-reported symptoms on pre- and post-intervention assessment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719964


Contacts
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Contact: Angelica Dilay, MPH angelica.n.dilay.ctr@mail.mil

Locations
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United States, California
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 92134
Contact: Brittany Powell, MD         
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Investigators
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Principal Investigator: Brittany E Powell, MD United States Naval Medical Center, San Diego

Publications:
Lumosity. Available from: http://www.lumosity.com.
Report to Congress on Mild Traumatic Brain Injury in the United States: Steps to Prevent a Serious Public Health Problem, N.C.f.I.P.a. Control, Editor 2003, Center for Disease Control Prevention: Atlanta, GA.
Zakzanis, K.K., L. Leach, and E. Kaplan, Neuropsychological differential diagnosis1999: Swets & Zeitlinger Publishers.
Tsaousides, T. and W.A. Gordon, Neuropsychological interventions following traumatic brain injury, in Traumatic Brain Injury: Rehabilitative Treatment and Case Management, M.J. Ashley, Editor 2010, CRC Press: Boca Raton, FL.
Sohlberg, M.M. and C.A. Mateer, Attention Process Training-3 (APT-3): A Direct Attention Training Program for the Remediation of the Attention Deficits: APT-3 Manual, 2010, Lash & Associates Publishing/Training Inc.: Youngsville, North Carolina.
Ben-Yishay, Y., E.B. Piasetsky, and J. Rattok, A systematic method for ameliorating disorders in basic attention. 1987.
Fasotti, L., et al., Time pressure management as a compensatory strategy training after closed head injury. Neuropsychological Rehabilitation, 2000. 10(1): p. 47-65.
Stephenson, C.L. and D.F. Halpern, Improved matrix reasoning is limited to training on tasks with a visuospatial component. Intelligence, 2013. 41(5): p. 341-357.
Mullins, L., et al., Video tracking of cancellation is sensitive to acute brain impairment and disability. Neurology, 2014. 82(P3): p. 226.
Bailie, J.M., et al., Neurobehavioral and Cognitive Impact of Mild Traumatic Brain injury: Potential Recruitment Bias, in 33rd Annual Meeting of the National Academy of Neuropsychology 2013, Archives of Clinical Neuropsychology: San Diego, CA.
Campbell, J.S., J.H. Greenberg, and J.M. Weil, Confronting mild-TBI and co-occuring PTSD symptoms in combat deployed service members, in Traumatic Brain Injury: A Neurologic Approach to Diagnosis, Management, and Rehabilitation, J.W. Tsao, Editor 2012, Springer Press: New Yor, NY.
Campbell, J.S., et al., Evaluation of Post-deployment Screening for Traumatic Brain Injury and Blast Exposure in a Sample of High-Risk Sailors Deployed to Iraq, in Coping with Blast-Related Traumatic Brain injury in Returning Troops2011, IOS Press: Washington, DC. p. 126-128.
Malec, J.F., Goal attainment scaling in rehabilitation. Neuropsychological Rehabilitation, 1999. 9(3-4): p. 253-275.
Stern, R.A. and T. White, Neuropsychological Assessment Battery: Administration, scoring, and interpretation manual, 2003, Psychological Assessment Resources: Lutz, FL.
Stern, R.A. and T. White, NAB Naming Test: Professional Manual, 2009, Psychological Assessment Resources: Lutz, FL.
Smith, A., Symbol Digits Modalities Test: Manual, 2007, Western Psychological Services: Los Angeles.
Weathers, F.W., J.A. Huska, and T.M. Keane, PTSD Checklist- Military Version (PCLM), 1991, National Center for PTSD- Behavioral Science Division.
Using the PTSD checklist U.S. Department of Veterans Affairs, V.N.C.f. PTSD, Editor 2012.

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Responsible Party: United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT02719964     History of Changes
Other Study ID Numbers: NMCSD.2015.0049
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by United States Naval Medical Center, San Diego:
Cognitive Training
Traumatic Brain Injury
Video Games

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries