Mild Traumatic Brain InjuryNCT03582579
Enhancing Brain Training With Virtual Reality
A study testing Training in Virtual Reality and Training on a computer screen in people with Mild Traumatic Brain Injury, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of brain training in a Virtual Reality set up in neurotypical populations as well as in the traumatic brain injury population. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Training in Virtual Reality and Training on a computer screen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2018to Sep 2025
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A person is eligible for inclusion in the study if he/she:
- Is an adult over the age of 18.
- Has the capacity to give consent.
- Has normal or corrected to normal vision.
- Has adequate hearing.
- Is a non-action video game player.
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- Is a non-VR game player. All subjects will be assigned to one of four groups: a Control Group training in VR, a Control Groups training on a 2D display, an Older Adult Group without dementia training in VR, and a College Athletes with mild TBI Group training in VR.
- Specific Inclusion Criteria for both Control Groups. The subject must:
- Be between the ages of 18 and 35.
- Have no neurologic or vascular disorders/injuries.
- Specific Inclusion Criteria for the College Athletes with TBI Group. The subject must:
- Be between the ages of 18 and 35.
- Be diagnosed with mild TBI (i.e., concussion) within the last two weeks.
- Specific Inclusion Criteria for the Older Adult Group. The subject must:
- Be over the age of 65.
- Have no neurologic or vascular disorders/injuries.
Who cannot join
- A person will be excluded from the study if he/she:
- Is under the age of 18.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effectiveness of brain training in a Virtual Reality set up in neurotypical populations as well as in the traumatic brain injury population.
Read the detailed description
Brain training is a large and a growing field, both scientifically and commercially. Emerging evidence demonstrates that training can promote beneficial brain plasticity in both healthy individuals and clinical populations. Much of the recent interest in brain training can be traced back to the seminal work done at the University of Rochester, where Daphne Bavelier and colleagues showed that training with action video games (AVG) can lead to a wide range of cognitive and perceptual improvements. In our recent work, we developed a novel training paradigm that isolates and concentrates the key aspects of AVG-training while eliminating complex and often violent gameplay associated with AVGs. The results revealed similarly broad effects of training as with conventional AVGs. In this study, we aim to move this training paradigm to virtual reality (VR) and extend its application to cognitive aging and mild traumatic brain injury (TBI) populations.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Training in Virtual Reality, Training on a computer screen
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in Virtual RealityBehavioural
Action Video Game Based Training in Virtual Reality
Training on a computer screenBehavioural
Action Video Game Based Training on a computer screen
| Study group | Role | What they receive |
|---|---|---|
| Control in VR | Experimental | Adults ages 18 to 35 who will be training in Virtual Reality. Receives: Behavioral: Training in Virtual Reality |
| Control Non-VR | Experimental | Adults ages 18 to 35 who will be training on a computer screen. Receives: Behavioral: Training on a computer screen |
| College Athletes with TBI Group | Experimental | Adults ages 18 to 35 with mild TBI who will be training in Virtual Reality Receives: Behavioral: Training in Virtual Reality |
| Older Adult Group | Experimental | Older Adults over the age of 65 who will be training in Virtual Reality Receives: Behavioral: Training in Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Crowding (a measure of spacial resolution of attention)
This is a visual task which will be done an a computer twice. Once prior to the start of training and then again following training. The results (including the number of trials correct as well as the time it took for the subject to respond) will be analyzed and compared across groups.
Measured: 6 weeks
Attentional Blink (a measure of temporal resolution of attention)
This is a visual task which will be done an a computer twice. Once prior to the start of training and then again following training. The results (including the number of trials correct as well as the time it took for the subject to respond) will be analyzed and compared across groups.
Measured: 6 weeks
Useful Field of View (a measure of spacial awareness)
This is a visual task which will be done an a computer twice. Once prior to the start of training and then again following training. The results (including the number of trials correct as well as the time it took for the subject to respond) will be analyzed and compared across groups.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start27 Jun 2018
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroTrainer
- Responsible party
- Principal investigator, Duje Tadin, University of Rochester
- Investigators
- Duje Tadin, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582579
- Sponsor's protocol ID
- 70869
- Status last verified
- Jul 2024
- First submitted
- 20 Mar 2018
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Brain Training With Virtual Reality
- ClinicalTrials.gov ID
- NCT03582579
- Acronym / sponsor ID
- 70869
- Conditions
- Mild Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- NeuroTrainer
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 11 Jul 2018 (actual)
- 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 purpose of this study is to evaluate the effectiveness of brain training in a Virtual Reality set up in neurotypical populations as well as in the traumatic brain injury population.
Detailed description
Brain training is a large and a growing field, both scientifically and commercially. Emerging evidence demonstrates that training can promote beneficial brain plasticity in both healthy individuals and clinical populations. Much of the recent interest in brain training can be traced back to the seminal work done at the University of Rochester, where Daphne Bavelier and colleagues showed that training with action video games (AVG) can lead to a wide range of cognitive and perceptual improvements. In our recent work, we developed a novel training paradigm that isolates and concentrates the key aspects of AVG-training while eliminating complex and often violent gameplay associated with AVGs. The results revealed similarly broad effects of training as with conventional AVGs. In this study, we aim to move this training paradigm to virtual reality (VR) and extend its application to cognitive aging and mild traumatic brain injury (TBI) populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control in VR | Experimental | Behavioral: Training in Virtual RealityAdults ages 18 to 35 who will be training in Virtual Reality. |
| Control Non-VR | Experimental | Behavioral: Training on a computer screenAdults ages 18 to 35 who will be training on a computer screen. |
| College Athletes with TBI Group | Experimental | Behavioral: Training in Virtual RealityAdults ages 18 to 35 with mild TBI who will be training in Virtual Reality |
| Older Adult Group | Experimental | Behavioral: Training in Virtual RealityOlder Adults over the age of 65 who will be training in Virtual Reality |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Is an adult over the age of 18.
- Has the capacity to give consent.
- Has normal or corrected to normal vision.
- Has adequate hearing.
- Is a non-action video game player.
Key exclusion criteria (2 listed)
- Is under the age of 18.
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 |
|---|---|---|
| Training in Virtual RealityAction Video Game Based Training in Virtual Reality | Behavioural | College Athletes with TBI Group, Control in VR, Older Adult Group |
| Training on a computer screenAction Video Game Based Training on a computer screen | Behavioural | Control Non-VR |
Primary outcome
Visual Crowding (a measure of spacial resolution of attention)
Time frame: 6 weeks
This is a visual task which will be done an a computer twice. Once prior to the start of training and then again following training. The results (including the number of trials correct as well as the time it took for the subject to respond) will be analyzed and compared across groups.
Attentional Blink (a measure of temporal resolution of attention)
Time frame: 6 weeks
This is a visual task which will be done an a computer twice. Once prior to the start of training and then again following training. The results (including the number of trials correct as well as the time it took for the subject to respond) will be analyzed and compared across groups.
Useful Field of View (a measure of spacial awareness)
Time frame: 6 weeks
This is a visual task which will be done an a computer twice. Once prior to the start of training and then again following training. The results (including the number of trials correct as well as the time it took for the subject to respond) will be analyzed and compared across groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- 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.
Duje Tadin, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in Virtual Reality and Training on a computer screen in people with Mild Traumatic Brain Injury, run by University of Rochester 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 16 inclusion and 2 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 5 Jul 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Crowding (a measure of spacial resolution of attention) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2024.