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Rehabilitation of Visual Attention Following mTBI

2019. március 11. frissítette: 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.

A tanulmány áttekintése

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Várható)

120

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

    • California
      • San Diego, California, Egyesült Államok, 92134
        • Toborzás
        • Naval Medical Center San Diego
        • Kapcsolatba lépni:
          • Brittany Powell, MD

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

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)

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.
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.
Kísérleti: 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.
Kísérleti: 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.
Kísérleti: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Post-Concussion Cognitive Symptoms
Időkeret: Two Months
Comparison of performance on pre- and post-intervention neuropsychological testing battery.
Two Months
Severity of Post-Concussive Symptoms
Időkeret: Two Months
Comparison of self-reported symptoms on pre- and post-intervention assessment.
Two Months

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Nyomozók

  • Kutatásvezető: Brittany E Powell, MD, United States Naval Medical Center, San Diego

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2016. május 1.

Elsődleges befejezés (Várható)

2020. október 1.

A tanulmány befejezése (Várható)

2020. október 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2016. március 21.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2016. március 21.

Első közzététel (Becslés)

2016. március 25.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2019. március 13.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2019. március 11.

Utolsó ellenőrzés

2019. március 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

ELDÖNTETLEN

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