Traumatic Brain InjuryNCT02719964
Rehabilitation of Visual Attention Following mTBI
A study testing Visual Attention Program (UCR Games), Speech Pathologist-Directed Therapy and General Cognitive Rehabilitation Games (Lumosity) in people with Traumatic Brain Injury, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Visual Attention Program (UCR Games), Speech Pathologist-Directed Therapy and General Cognitive Rehabilitation Games (Lumosity)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Angelica Dilay, MPH contact
United States1 site, 1 recruiting
- Recruiting
Naval Medical Center San Diego
San Diego, California, 92134
Brittany Powell, MD
About this study
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.
Read the 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:
- 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Visual Attention Program (UCR Games), Speech Pathologist-Directed Therapy, General Cognitive Rehabilitation Games (Lumosity)
- Keywords
- Cognitive Training, Traumatic Brain Injury, Video Games
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Speech Pathologist-Directed TherapyOther
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)Other
Lumosity is a commercially available computerized program purported to enhance cognitive functioning through a variety of computerized programs that utilize various cognitive abilities.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Speech Pathologist-Directed Therapy; Other: General Cognitive Rehabilitation Games (Lumosity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Concussion Cognitive Symptoms
Comparison of performance on pre- and post-intervention neuropsychological testing battery.
Measured: Two Months
Severity of Post-Concussive Symptoms
Comparison of self-reported symptoms on pre- and post-intervention assessment.
Measured: Two Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (83)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Brittany E Powell, MD, Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719964
- Sponsor's protocol ID
- NMCSD.2015.0049
- Status last verified
- Mar 2019
- First submitted
- 21 Mar 2016
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Deveau J, Ozer DJ, Seitz AR. Improved vision and on-field performance in baseball through perceptual learning. Curr Biol. 2014 Feb 17;24(4):R146-7. doi: 10.1016/j.cub.2014.01.004. No abstract available.
PubMed 24556432Lumosity. Available from: http://www.lumosity.com.
Carey ME. Learning from traditional combat mortality and morbidity data used in the evaluation of combat medical care. Mil Med. 1987 Jan;152(1):6-13. No abstract available.
PubMed 3103012Hoge CW, McGurk D, Thomas JL, Cox AL, Engel CC, Castro CA. Mild traumatic brain injury in U.S. Soldiers returning from Iraq. N Engl J Med. 2008 Jan 31;358(5):453-63. doi: 10.1056/NEJMoa072972. Epub 2008 Jan 30.
PubMed 18234750Schneiderman AI, Braver ER, Kang HK. Understanding sequelae of injury mechanisms and mild traumatic brain injury incurred during the conflicts in Iraq and Afghanistan: persistent postconcussive symptoms and posttraumatic stress disorder. Am J Epidemiol. 2008 Jun 15;167(12):1446-52. doi: 10.1093/aje/kwn068. Epub 2008 Apr 17.
PubMed 18424429Schwab KA, Ivins B, Cramer G, Johnson W, Sluss-Tiller M, Kiley K, Lux W, Warden D. Screening for traumatic brain injury in troops returning from deployment in Afghanistan and Iraq: initial investigation of the usefulness of a short screening tool for traumatic brain injury. J Head Trauma Rehabil. 2007 Nov-Dec;22(6):377-89. doi: 10.1097/01.HTR.0000300233.98242.87.
PubMed 18025970Terrio H, Brenner LA, Ivins BJ, Cho JM, Helmick K, Schwab K, Scally K, Bretthauer R, Warden D. Traumatic brain injury screening: preliminary findings in a US Army Brigade Combat Team. J Head Trauma Rehabil. 2009 Jan-Feb;24(1):14-23. doi: 10.1097/HTR.0b013e31819581d8.
PubMed 19158592Report 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.
Binder LM, Rohling ML, Larrabee GJ. A review of mild head trauma. Part I: Meta-analytic review of neuropsychological studies. J Clin Exp Neuropsychol. 1997 Jun;19(3):421-31. doi: 10.1080/01688639708403870.
PubMed 9268816Zakzanis, K.K., L. Leach, and E. Kaplan, Neuropsychological differential diagnosis1999: Swets & Zeitlinger Publishers.
Belanger HG, Curtiss G, Demery JA, Lebowitz BK, Vanderploeg RD. Factors moderating neuropsychological outcomes following mild traumatic brain injury: a meta-analysis. J Int Neuropsychol Soc. 2005 May;11(3):215-27. doi: 10.1017/S1355617705050277.
PubMed 15892898Belanger HG, Vanderploeg RD. The neuropsychological impact of sports-related concussion: a meta-analysis. J Int Neuropsychol Soc. 2005 Jul;11(4):345-57. doi: 10.1017/s1355617705050411.
PubMed 16209414Tsaousides, 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 MM, Mateer CA. Improving attention and managing attentional problems. Adapting rehabilitation techniques to adults with ADD. Ann N Y Acad Sci. 2001 Jun;931:359-75.
PubMed 11462753Sohlberg, 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Visual Attention Following mTBI
- ClinicalTrials.gov ID
- NCT02719964
- Acronym / sponsor ID
- NMCSD.2015.0049
- Conditions
- Traumatic Brain Injury
- Keywords
- Cognitive Training, Traumatic Brain Injury, Video Games
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- May 2016
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A: UCR Games→SP-Directed Therapy | Experimental | Other: Visual Attention Program (UCR Games), Other: Speech Pathologist-Directed TherapyParticipants 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. |
| B: Lumosity→SP-Directed Therapy | Experimental | Other: Speech Pathologist-Directed Therapy, Other: General Cognitive Rehabilitation Games (Lumosity)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. |
| C: SP-Directed Therapy→UCR Games | Experimental | Other: Visual Attention Program (UCR Games), Other: Speech Pathologist-Directed TherapyParticipants 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. |
| D: SP-Directed Therapy→Lumosity | Experimental | Other: Speech Pathologist-Directed Therapy, Other: General Cognitive Rehabilitation Games (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | A: UCR Games→SP-Directed Therapy, C: SP-Directed Therapy→UCR Games |
| Speech Pathologist-Directed TherapyThis 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 | 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)Lumosity is a commercially available computerized program purported to enhance cognitive functioning through a variety of computerized programs that utilize various cognitive abilities. | Other | B: Lumosity→SP-Directed Therapy, D: SP-Directed Therapy→Lumosity |
Primary outcome
Post-Concussion Cognitive Symptoms
Time frame: Two Months
Comparison of performance on pre- and post-intervention neuropsychological testing battery.
Severity of Post-Concussive Symptoms
Time frame: Two Months
Comparison of self-reported symptoms on pre- and post-intervention assessment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Background: PubMed 24556432Deveau J, Ozer DJ, Seitz AR. Improved vision and on-field performance in baseball through perceptual learning. Curr Biol. 2014 Feb 17;24(4):R146-7. doi: 10.1016/j.cub.2014.01.004. No abstract available.
- BackgroundLumosity. Available from: http://www.lumosity.com.
- Background: PubMed 3103012Carey ME. Learning from traditional combat mortality and morbidity data used in the evaluation of combat medical care. Mil Med. 1987 Jan;152(1):6-13. No abstract available.
- Background: PubMed 18234750Hoge CW, McGurk D, Thomas JL, Cox AL, Engel CC, Castro CA. Mild traumatic brain injury in U.S. Soldiers returning from Iraq. N Engl J Med. 2008 Jan 31;358(5):453-63. doi: 10.1056/NEJMoa072972. Epub 2008 Jan 30.
- Background: PubMed 18424429Schneiderman AI, Braver ER, Kang HK. Understanding sequelae of injury mechanisms and mild traumatic brain injury incurred during the conflicts in Iraq and Afghanistan: persistent postconcussive symptoms and posttraumatic stress disorder. Am J Epidemiol. 2008 Jun 15;167(12):1446-52. doi: 10.1093/aje/kwn068. Epub 2008 Apr 17.
- Background: PubMed 18025970Schwab KA, Ivins B, Cramer G, Johnson W, Sluss-Tiller M, Kiley K, Lux W, Warden D. Screening for traumatic brain injury in troops returning from deployment in Afghanistan and Iraq: initial investigation of the usefulness of a short screening tool for traumatic brain injury. J Head Trauma Rehabil. 2007 Nov-Dec;22(6):377-89. doi: 10.1097/01.HTR.0000300233.98242.87.
- Background: PubMed 19158592Terrio H, Brenner LA, Ivins BJ, Cho JM, Helmick K, Schwab K, Scally K, Bretthauer R, Warden D. Traumatic brain injury screening: preliminary findings in a US Army Brigade Combat Team. J Head Trauma Rehabil. 2009 Jan-Feb;24(1):14-23. doi: 10.1097/HTR.0b013e31819581d8.
- BackgroundReport 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.
- Background: PubMed 9268816Binder LM, Rohling ML, Larrabee GJ. A review of mild head trauma. Part I: Meta-analytic review of neuropsychological studies. J Clin Exp Neuropsychol. 1997 Jun;19(3):421-31. doi: 10.1080/01688639708403870.
- BackgroundZakzanis, K.K., L. Leach, and E. Kaplan, Neuropsychological differential diagnosis1999: Swets & Zeitlinger Publishers.
- Background: PubMed 15892898Belanger HG, Curtiss G, Demery JA, Lebowitz BK, Vanderploeg RD. Factors moderating neuropsychological outcomes following mild traumatic brain injury: a meta-analysis. J Int Neuropsychol Soc. 2005 May;11(3):215-27. doi: 10.1017/S1355617705050277.
- Background: PubMed 16209414Belanger HG, Vanderploeg RD. The neuropsychological impact of sports-related concussion: a meta-analysis. J Int Neuropsychol Soc. 2005 Jul;11(4):345-57. doi: 10.1017/s1355617705050411.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelica Dilay, MPH contact
Brittany E Powell, MD principal investigator
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Attention Program (UCR Games), Speech Pathologist-Directed Therapy and General Cognitive Rehabilitation Games (Lumosity) in people with Traumatic Brain Injury, run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angelica Dilay, MPH (angelica.n.dilay.ctr@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Concussion Cognitive Symptoms (time frame: Two Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02719964, which also lists 83 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.