Rehabilitation of Visual Attention Following mTBI

NCT02719964 | Unknown

• 1 other identifier: NMCSD.2015.0049
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Cognitive Training; Traumatic Brain Injury; Video Games

Outcome Measures

Primary Outcomes (2)

• Post-Concussion Cognitive Symptoms

  Comparison of performance on pre- and post-intervention neuropsychological testing battery.

  Two Months

• Severity of Post-Concussive Symptoms

  Comparison of self-reported symptoms on pre- and post-intervention assessment.

  Two Months

Study Arms (4)

A: UCR Games→SP-Directed Therapy

EXPERIMENTAL

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); Other: Speech Pathologist-Directed Therapy

B: Lumosity→SP-Directed Therapy

EXPERIMENTAL

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; Other: General Cognitive Rehabilitation Games (Lumosity)

C: SP-Directed Therapy→UCR Games

EXPERIMENTAL

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); Other: Speech Pathologist-Directed Therapy

D: SP-Directed Therapy→Lumosity

EXPERIMENTAL

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; Other: General Cognitive Rehabilitation Games (Lumosity)

Interventions

Visual Attention Program (UCR Games) OTHER

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.

A: UCR Games→SP-Directed Therapy; C: SP-Directed Therapy→UCR Games

Speech Pathologist-Directed Therapy OTHER

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.

A: UCR Games→SP-Directed Therapy; B: Lumosity→SP-Directed Therapy; C: SP-Directed Therapy→UCR Games; D: SP-Directed Therapy→Lumosity

General Cognitive Rehabilitation Games (Lumosity) OTHER

Lumosity is a commercially available computerized program purported to enhance cognitive functioning through a variety of computerized programs that utilize various cognitive abilities.

B: Lumosity→SP-Directed Therapy; D: SP-Directed Therapy→Lumosity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

RECRUITING

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MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Brittany E Powell, MD

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelica Dilay, MPH

CONTACT

angelica.n.dilay.ctr@mail.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: March 25, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

US (1)