TBI (Traumatic Brain Injury)NCT04526639
VR Cognitive Rehabiliation for Pediatric TBI
A study testing Virtual Reality-based Interactive Cognitive Training Program in people with TBI (Traumatic Brain Injury), run by University of Massachusetts, Lowell at 2 sites in United States.
Trial summary
Childhood traumatic brain injury (TBI) poses significant impairment in children's executive functions (EFs) for moderate to severe injuries, yet interventions specifically designed for children's EF rehabilitation post-TBI and rigorous clinical trials to establish the efficacy of such interventions remain unavailable. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- Virtual Reality-based Interactive Cognitive Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Sep 2021to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosed with TBI within the past 12 months and under 18 years at the time of injury;
- fluent in English; and 3) Score <28 on the Agitated Behavior Scale (if available).
Who cannot join
- comorbidities or premorbid disorders that prevent proper administration of VR and study measures,
- restriction from using electronic devices,
- post-injury seizure activity.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114
About this study
Official title: Virtual Reality-based Rehabilitation for Pediatric TBI (R00 Phase)
Childhood traumatic brain injury (TBI) poses significant impairment in children's executive functions (EFs) for moderate to severe injuries, yet interventions specifically designed for children's EF rehabilitation post-TBI and rigorous clinical trials to establish the efficacy of such interventions remain unavailable. In this study, the investigators will conduct a randomized clinical trial to evaluate the efficacy of a novel virtual reality (VR)-based training program for EF rehabilitation for childhood TBI.
Read the detailed description
Traumatic brain injury (TBI) is a leading cause of acquired disability in U.S. children, with an estimated 700,000 cases every year, presenting in 75% of children with trauma and accounting for 70% of deaths from childhood trauma. Childhood TBIs often result in significant impairment in cognitive functions,1 particularly in core executive functions (EFs) due to the vulnerability of the frontal lobes, especially after a moderate to severe TBI. Core EF is composed of three skills: inhibitory control, working memory, and cognitive flexibility. These skills are associated with impaired EF behaviors, increased attention problems, and lower health-related quality-of-life (HRQOL). However, evidence-based EF rehabilitation programs are lacking. Although a combination of diverse cognitive interventions may improve children's EF, limited affordability, accessibility, adherence, and generalizability hamper clinically adapting and implementing such interventions in the rehabilitation setting. Virtual reality (VR) offers an exciting alternative strategy for EF rehabilitation of childhood TBI due to its flexibility, accessibility, and immersive experiences in three dimensions. These properties may increase adherence to training and foster an enhanced transfer of learned EF skills to untrained tasks in everyday life. Thus far, rigor-ous randomized clinical trials (RCTs) have not been conducted to establish the efficacy of VR-based EF reha-bilitation for childhood TBI.
The overall goal of the project is to assess the efficacy of a novel VR-based interactive cognitive training (VICT) program for EF rehabilitation in children with TBI with the following aims:
Aim 1. Examine VICT's efficacy in improving core and daily EF skills among children with TBI.
Hypothesis 1.1: Children in the intervention group will show enhanced improvement over controls in trained VR-based EF tasks and untrained NIH Toolbox tasks from baseline to post-intervention and follow-up visits; Hypothesis 1.2: The intervention group will show better reported daily EF than controls at the follow-up visit; Hypothesis 1.3: Children in the intervention group will show faster improvement than controls in daily-reported EF skills between post-intervention and follow-up visits.
Aim 2. Examine VICT's efficacy in reducing attentional problems among children with TBI.
Hypothesis 2.1: Children in the intervention group will show a greater reduction in attentional problems as measured by testing on the Conners Continuous Performance Test 3rd Edition™ (Conners CPT 3TM) from baseline to the post-intervention and follow-up visits than controls; Hypothesis 2.2: Children in the intervention group will show fewer everyday attentional problems on the Be-havior Assessment System for Children 3rd Ed (BASC-3) self- and parent-ratings of attention at the follow-up visit than controls; Hypothesis 2.3: The direct effect of the VICT program in reducing attention problems will be mediated by children's EF behaviors as measured by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2) at the follow-up visit.
Aim 3. Examine VICT's efficacy in improving HRQOL among children with TBI. Hypothesis 3.1: The intervention group will show higher levels of reported HRQOL than controls at follow-up; Hypothesis 3.2: The direct effect of the VICT program on HRQOL at follow-up will be mediated by children's EF skills and ratings of EF behaviors and attention at the post-intervention and follow-up visits.
- Conditions
- TBI (Traumatic Brain Injury)
- Being tested
- Virtual Reality-based Interactive Cognitive Training Program, Placebo Virtual Reality Game
- 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.
Virtual Reality-based Interactive Cognitive Training ProgramBehavioural
Three virtual reality-based games designed to train inhibitory control, working memory, and cognitive flexibility among children with TBI
Placebo Virtual Reality GameBehavioural
A virtual playground for control group to interact without training executive functions
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality games for training executive functions | Experimental | Virtual Reality games for training three core executive functions Receives: Behavioral: Virtual Reality-based Interactive Cognitive Training Program |
| Control VR Game on Playground | Placebo comparator | A relaxing virtual reality game for control group to play in VR playground without training their executive functions Receives: Behavioral: Placebo Virtual Reality Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
VR-based EF Assessment Task
Performance-based executive function assessment Task in the virtual reality environment built by the research team. There are three tasks within this measurement, each transformed into a z score and summed up to serve as the total score for this measure. A Z-score of 0 in each task represents the sample mean. Higher values represent a better outcome for this measure.
Measured: Baseline (at recruitment/before intervention), Post-Intervention (after completion of intervention, up to 2 weeks), Follow-Up (up to 6 months after completion of intervention)
Secondary outcomes (3)
NIH Toolbox Cognition Battery
Performance-based executive functions tested by three tasks in the NIH Toolbox Cognition Battery: Dimensional Change Card Sort Test, List Sorting Working Memory Test, and Flanker Inhibitory Control and Attention Test. Scores of each task were computed as age-corrected standard scores automatically by the iPad app of the NIH Toolbox Cognition Battery. Each age-corrected standard score is a z-score with a mean of 100 and standard deviation of 15. Total scores are the mean of all three task age-corrected standard scores. Higher scores represent better outcomes.
Measured: Baseline (at recruitment/before intervention), Post-Intervention (after completion of intervention, up to 2 weeks), Follow-Up (up to 6 months after completion of intervention)
Report-based EF Skills
Behavior Rating Inventory of Executive Function 2; T scores are used (M = 50, SD = 10, no lower/upper limit), T scores from 60 to 64 are considered mildly elevated, and T scores from 65 to 69 are considered potentially clinically elevated. T scores at or above 70 are considered clinically elevated
Measured: Follow-Up (up to 6 months after completion of intervention)
Health-related Quality of Life
23-item PedsQL (Pediatric Quality of Life) Generic Core Scales were designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. The current study uses its total scores, which is the sum of all 23 items and ranges from 0-100 after transformation. Higher scores indicate better quality of life.
Measured: Follow-Up (up to 6 months after completion of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start3 Sep 2021
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TBI (Traumatic Brain Injury)Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Lowell
- Sponsor type
- University, hospital or other
- Collaborators
- Spaulding Rehabilitation Hospital, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Responsible party
- Principal investigator, Jiabin Shen, PhD, University of Massachusetts, Lowell
- Investigators
- Jiabin Shen, PhD, Principal investigator, University of Massachusetts, Lowell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526639
- Sponsor's protocol ID
- R00HD093814
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2020
- Last updated
- 16 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified datasets and associated documents will be deposited and made available to the public through NICHD Data and Specimen Hub (DASH). DASH has policies and procedures in place that are fully consistent with the NIH Data Sharing Policies and applicable laws and regulations. The final dataset will include demographic and clinical data associated with the nature and severity of patients' injuries, self/parent-reported psychological and behavioral data, performance data on cognitive outcomes. Submitted data will confirm with relevant data and terminology standards as well as policies at NIH, NICHD, and DASH.
Publications
Shen J, Wang Y, Quinn S, Suskauer SJ, Birch J, Busch T, Svingos A, Crawfis R, Yeates KO, Taylor HG. Efficacy of a virtual reality-based cognitive interactive training program for children with traumatic brain injuries: study protocol for a parallel-group randomized controlled trial. Trials. 2024 Mar 13;25(1):185. doi: 10.1186/s13063-024-08049-1.
PubMed 38481293
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-based Rehabilitation for Pediatric TBI (R00 Phase)
- ClinicalTrials.gov ID
- NCT04526639
- Acronym / sponsor ID
- R00HD093814
- Conditions
- TBI (Traumatic Brain Injury)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Massachusetts, LowellUniversity, hospital or other
- Collaborators
- Spaulding Rehabilitation Hospital, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 26 Aug 2020 (actual)
- Results
- Posted 16 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Childhood traumatic brain injury (TBI) poses significant impairment in children's executive functions (EFs) for moderate to severe injuries, yet interventions specifically designed for children's EF rehabilitation post-TBI and rigorous clinical trials to establish the efficacy of such interventions remain unavailable. In this study, the investigators will conduct a randomized clinical trial to evaluate the efficacy of a novel virtual reality (VR)-based training program for EF rehabilitation for childhood TBI.
Detailed description
Traumatic brain injury (TBI) is a leading cause of acquired disability in U.S. children, with an estimated 700,000 cases every year, presenting in 75% of children with trauma and accounting for 70% of deaths from childhood trauma. Childhood TBIs often result in significant impairment in cognitive functions,1 particularly in core executive functions (EFs) due to the vulnerability of the frontal lobes, especially after a moderate to severe TBI. Core EF is composed of three skills: inhibitory control, working memory, and cognitive flexibility. These skills are associated with impaired EF behaviors, increased attention problems, and lower health-related quality-of-life (HRQOL). However, evidence-based EF rehabilitation programs are lacking. Although a combination of diverse cognitive interventions may improve children's EF, limited affordability, accessibility, adherence, and generalizability hamper clinically adapting and implementing such interventions in the rehabilitation setting. Virtual reality (VR) offers an exciting alternative strategy for EF rehabilitation of childhood TBI due to its flexibility, accessibility, and immersive experiences in three dimensions. These properties may increase adherence to training and foster an enhanced transfer of learned EF skills to untrained tasks in everyday life. Thus far, rigor-ous randomized clinical trials (RCTs) have not been conducted to establish the efficacy of VR-based EF reha-bilitation for childhood TBI.
The overall goal of the project is to assess the efficacy of a novel VR-based interactive cognitive training (VICT) program for EF rehabilitation in children with TBI with the following aims:
Aim 1. Examine VICT's efficacy in improving core and daily EF skills among children with TBI.
Hypothesis 1.1: Children in the intervention group will show enhanced improvement over controls in trained VR-based EF tasks and untrained NIH Toolbox tasks from baseline to post-intervention and follow-up visits; Hypothesis 1.2: The intervention group will show better reported daily EF than controls at the follow-up visit; Hypothesis 1.3: Children in the intervention group will show faster improvement than controls in daily-reported EF skills between post-intervention and follow-up visits.
Aim 2. Examine VICT's efficacy in reducing attentional problems among children with TBI.
Hypothesis 2.1: Children in the intervention group will show a greater reduction in attentional problems as measured by testing on the Conners Continuous Performance Test 3rd Edition™ (Conners CPT 3TM) from baseline to the post-intervention and follow-up visits than controls; Hypothesis 2.2: Children in the intervention group will show fewer everyday attentional problems on the Be-havior Assessment System for Children 3rd Ed (BASC-3) self- and parent-ratings of attention at the follow-up visit than controls; Hypothesis 2.3: The direct effect of the VICT program in reducing attention problems will be mediated by children's EF behaviors as measured by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2) at the follow-up visit.
Aim 3. Examine VICT's efficacy in improving HRQOL among children with TBI. Hypothesis 3.1: The intervention group will show higher levels of reported HRQOL than controls at follow-up; Hypothesis 3.2: The direct effect of the VICT program on HRQOL at follow-up will be mediated by children's EF skills and ratings of EF behaviors and attention at the post-intervention and follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality games for training executive functions | Experimental | Behavioral: Virtual Reality-based Interactive Cognitive Training ProgramVirtual Reality games for training three core executive functions |
| Control VR Game on Playground | Placebo comparator | Behavioral: Placebo Virtual Reality GameA relaxing virtual reality game for control group to play in VR playground without training their executive functions |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- diagnosed with TBI within the past 12 months and under 18 years at the time of injury;
- fluent in English; and 3) Score <28 on the Agitated Behavior Scale (if available).
Key exclusion criteria (3 listed)
- comorbidities or premorbid disorders that prevent proper administration of VR and study measures,
- restriction from using electronic devices,
- post-injury seizure activity.
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 |
|---|---|---|
| Virtual Reality-based Interactive Cognitive Training ProgramThree virtual reality-based games designed to train inhibitory control, working memory, and cognitive flexibility among children with TBI | Behavioural | Virtual Reality games for training executive functions |
| Placebo Virtual Reality GameA virtual playground for control group to interact without training executive functions | Behavioural | Control VR Game on Playground |
Primary outcome
VR-based EF Assessment Task
Time frame: Baseline (at recruitment/before intervention), Post-Intervention (after completion of intervention, up to 2 weeks), Follow-Up (up to 6 months after completion of intervention)
Performance-based executive function assessment Task in the virtual reality environment built by the research team. There are three tasks within this measurement, each transformed into a z score and summed up to serve as the total score for this measure. A Z-score of 0 in each task represents the sample mean. Higher values represent a better outcome for this measure.
3 secondary outcomes
NIH Toolbox Cognition Battery
Time frame: Baseline (at recruitment/before intervention), Post-Intervention (after completion of intervention, up to 2 weeks), Follow-Up (up to 6 months after completion of intervention)
Report-based EF Skills
Time frame: Follow-Up (up to 6 months after completion of intervention)
Health-related Quality of Life
Time frame: Follow-Up (up to 6 months after completion of intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38481293Shen J, Wang Y, Quinn S, Suskauer SJ, Birch J, Busch T, Svingos A, Crawfis R, Yeates KO, Taylor HG. Efficacy of a virtual reality-based cognitive interactive training program for children with traumatic brain injuries: study protocol for a parallel-group randomized controlled trial. Trials. 2024 Mar 13;25(1):185. doi: 10.1186/s13063-024-08049-1.
- Individual participant dataSharing planned: Yes. The de-identified datasets and associated documents will be deposited and made available to the public through NICHD Data and Specimen Hub (DASH). DASH has policies and procedures in place that are fully consistent with the NIH Data Sharing Policies and applicable laws and regulations. The final dataset will include demographic and clinical data associated with the nature and severity of patients' injuries, self/parent-reported psychological and behavioral data, performance data on cognitive outcomes. Submitted data will confirm with relevant data and terminology standards as well as policies at NIH, NICHD, and DASH.
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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.
Jiabin Shen, PhD principal investigator
University of Massachusetts, Lowell
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-based Interactive Cognitive Training Program in people with TBI (Traumatic Brain Injury), run by University of Massachusetts, Lowell at 2 sites 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
VR-based EF Assessment Task (time frame: Baseline (at recruitment/before intervention), Post-Intervention (after completion of intervention, up to 2 weeks), Follow-Up (up to 6 months after completion of intervention)). 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 NCT04526639, which also lists 1 linked publication.
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 16 Oct 2025.