Recruiting

Rehabilitation

Sponsor:

United States Naval Medical Center, San Diego

Code:

NCT02719964

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Visual Attention Program (UCR Games)

Speech Pathologist-Directed Therapy

General Cognitive Rehabilitation Games (Lumosity)

Study Details

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.

Conditions

Traumatic Brain Injury

Study ID

NCT02719964

Start date

May, 2016

Status verified date

Mar, 2019

Completion date

Oct, 2020

Anticipated

Primary completion date

Oct, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

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.

Primary outcome measure

  • Post-Concussion Cognitive Symptoms [ Time Frame: Two Months ]
  • Severity of Post-Concussive Symptoms [ Time Frame: Two Months ]

Central Contacts and Locations

Central contacts

Angelica Dilay, MPH

angelica.n.dilay.ctr@mail.mil

Locations

Naval Medical Center San Diego

Recruiting

San Diego, California, United States, 92134

More Information

Sponsor

United States Naval Medical Center, San Diego

Last update posted

Mar 13, 2019

Last verified

Mar, 2019

Keywords

  • Cognitive Training
  • Traumatic Brain Injury
  • Video Games

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Naval Medical Center, San Diego on 2019-03-13.