Rehabilitation of Visual Attention Following mTBI
11 maart 2019 bijgewerkt door: United States Naval Medical Center, San Diego
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.
Studie Overzicht
Toestand
Onbekend
Conditie
Gedetailleerde beschrijving
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:
- Visual Attention and Memory Program (UCR Games)
- Cognitive and Psychological Based Rehabilitation (Speech Pathologist-Directed Therapy)
- 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.
Studietype
Ingrijpend
Inschrijving (Verwacht)
120
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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San Diego, California, Verenigde Staten, 92134
- Werving
- Naval Medical Center San Diego
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Contact:
- Brittany Powell, MD
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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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.
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.
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Experimenteel: 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.
|
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.
Lumosity is a commercially available computerized program purported to enhance cognitive functioning through a variety of computerized programs that utilize various cognitive abilities.
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Experimenteel: 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.
|
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.
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.
|
|
Experimenteel: 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.
|
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.
Lumosity is a commercially available computerized program purported to enhance cognitive functioning through a variety of computerized programs that utilize various cognitive abilities.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Post-Concussion Cognitive Symptoms
Tijdsspanne: Two Months
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Comparison of performance on pre- and post-intervention neuropsychological testing battery.
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Two Months
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Severity of Post-Concussive Symptoms
Tijdsspanne: Two Months
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Comparison of self-reported symptoms on pre- and post-intervention assessment.
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Two Months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Brittany E Powell, MD, United States Naval Medical Center, San Diego
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2016
Primaire voltooiing (Verwacht)
1 oktober 2020
Studie voltooiing (Verwacht)
1 oktober 2020
Studieregistratiedata
Eerst ingediend
21 maart 2016
Eerst ingediend dat voldeed aan de QC-criteria
21 maart 2016
Eerst geplaatst (Schatting)
25 maart 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 maart 2019
Laatste update ingediend die voldeed aan QC-criteria
11 maart 2019
Laatst geverifieerd
1 maart 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NMCSD.2015.0049
Plan Individuele Deelnemersgegevens (IPD)
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ONBESLIST
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