Traumatic Brain InjuryNCT04356963

Adjunct VR Pain Management in Acute Brain Injury

A study testing Virtual Reality Session (VR Blu), Tablet-based Session (Tablet Blu) and Use of Virtual Reality Head Mounted Display without Content (VR Blank) in people with Traumatic Brain Injury and Headaches Posttraumatic, run by University of Maryland, Baltimore at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Severe and refractory pain after acute injury is a known-risk factor for chronic opioid use disorder. In this study, the investigators will use Virtual Reality (VR) immersion as a non-pharmacological adjunct to treat pain associated with acute traumatic injuries, including traumatic brain injury. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Traumatic Brain Injury, Headaches Posttraumatic, Trauma
What is being tested?: Virtual Reality Session (VR Blu), Tablet-based Session (Tablet Blu) and Use of Virtual Reality Head Mounted Display without Content (VR Blank)
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 2 sitesUnited States
Study dates: 5 Sep 2020to 30 Apr 2022
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of Traumatic Injury (including but not limited to traumatic brain injury)
Age greater than or equal to 18 years-old
Endorsing at least moderate pain as defined by documentation of at least one numeric rating pain scale score of 3 or more in the last 24 hours.
Glasgow Coma Scale of 15
Expected to stay in the hospital for at least 12 hours after enrollment

Who cannot join

Seizure prior to enrollment
Pregnancy
non-English speaking
Known intolerance of Virtual Reality
Patient unable to consent for themselves

Trial locations and contacts

2 sites in 1 country.

United States2 sites

R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
University of Maryland Medical Center
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Adjunct Virtual Reality Pain Management in Acute Brain Injury

Read the detailed description

Each participant will undergo one VR session and two control sessions. The VR session will take place in a commercially available VR environment, the Blu, and last 20-30 minutes (VR Blu). The control sessions will include a 2D-tablet based session that mimics the VR content (Tablet Blu) and a content-less placement of the VR headset (VR Blank). The order of these sessions will be randomized across participants are intended to complete all sessions.

Each participant will complete a pre-study questionnaire to elicit their prior experience with the virtual reality as well as measures of gaming addiction/engagement, boredom, and expectancy. These scales will help us determine which patient-level factors predict response to VR. Before and after each session, participants will complete validated scales of pain, nausea, and anxiety.. Pre- and Post-VR opioid use will be recorded. Basic vital signs including heart rate, blood pressure, and respiratory rate, will be recorded before and after each session to monitor autonomic response. Advanced measures of autonomic response will include heart rate variability,,and pupillometry metrics. At the conclusion of all sessions, participants will complete another questionnaire to document their subjective experience of using VR (perceived effectiveness)

Conditions: Traumatic Brain Injury, Headaches Posttraumatic, Trauma, Pain, Acute
Being tested: Virtual Reality Session (VR Blu), Tablet-based Session (Tablet Blu), Use of Virtual Reality Head Mounted Display without Content (VR Blank)
Medical subject headings: Brain Injuries, Traumatic, Post-Traumatic Headache, Wounds and Injuries, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual Reality Session (VR Blu)Behavioural
20-30 minute session of virtual reality immersive content.
Tablet-based Session (Tablet Blu)Behavioural
20-30 minute session of tablet-based content that mimics the content from virtual reality sessions.
Use of Virtual Reality Head Mounted Display without Content (VR Blank)Behavioural
20-30 minutes session using head mounted display to reduce light and sound.

Study groups in NCT04356963
Study group	Role	What they receive
All patients	Experimental	All patients were intended to engage in three different 20-30 min sessions run by research coordinators and spaced a minimum of 4 hours apart to allow for washout of effects, including 1) a commercially available, immersive VR environment, theBlu (WEVR, Inc, Venice, California, USA) delivered via Oculus Rift (Oculus VR, Irvine, California, USA) headset (VR Blu), 2) a non-immersive two-dimensional mimic delivered via a tablet computer (Tablet Blu), and 3) a VR control session delivered via a content-less Oculus Rift headset (VR Blank). The three sessions were run by research coordinators and spaced a minimum of 4 hours apart. The intervention order was counterbalanced using a randomized sequence generator. Receives: Behavioral: Virtual Reality Session (VR Blu); Behavioral: Tablet-based Session (Tablet Blu); Behavioral: Use of Virtual Reality Head Mounted Display without Content (VR Blank)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Pain Score
Pre- vs. Post-Intervention Ratings on Numeric Pain Rating Scale. Numeric Pain Rating scale range is from 0 (no pain) -10 (severe pain)
Measured: Pre- and Post-Intervention (approximately 30 minutes)

Secondary outcomes (1)

Opioid Administration
Change in amount of opioids received in the 4 hours post-intervention vs. the 4 hours pre-intervention in morphine equivalents
Measured: 4 hours post-intervention vs. 4 hours pre-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Sep 202030 Apr 2022

First posted22 Apr 2020
Study start5 Sep 2020
Primary completion7 Jan 2022
Study completion30 Apr 2022

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 (2)Papers the sponsor has linked to this study.
Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Model description: Within-Subjects Design. All participants (single group, 1 arm) intended to complete all three sessions (interventions) in randomized order. At least 4 hours were required to pass between each session to allow for washout.
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04356963
Sponsor's protocol ID: HP - 00090603
Other IDs: 1UL1TR003098
Status last verified: Apr 2023
First submitted: 19 Apr 2020
Last updated: 24 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Morris NA, Wang Y, Felix RB, Rao A, Arnold S, Khalid M, Armahizer MJ, Murthi SB, Colloca L. Adjunctive virtual reality pain relief after traumatic injury: a proof-of-concept within-person randomized trial. Pain. 2023 Sep 1;164(9):2122-2129. doi: 10.1097/j.pain.0000000000002914. Epub 2023 Apr 19.
PubMed 37079851
Felix RB, Rao A, Khalid M, Wang Y, Colloca L, Murthi SB, Morris NA. Adjunctive virtual reality pain relief following traumatic injury: protocol for a randomised within-subjects clinical trial. BMJ Open. 2021 Nov 30;11(11):e056030. doi: 10.1136/bmjopen-2021-056030.
PubMed 34848527

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma

All Traumatic Brain Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adjunct Virtual Reality Pain Management in Acute Brain Injury
ClinicalTrials.gov ID: NCT04356963
Acronym / sponsor ID: HP - 00090603
Conditions: Traumatic Brain Injury, Headaches Posttraumatic, Trauma, Pain, Acute
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Study start: 5 Sep 2020 (actual)
Primary completion: 7 Jan 2022 (actual)
Study completion: 30 Apr 2022 (actual)
First posted: 22 Apr 2020 (actual)
Results: Posted 24 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Within-Subjects Design. All participants (single group, 1 arm) intended to complete all three sessions (interventions) in randomized order. At least 4 hours were required to pass between each session to allow for washout.

Arm	Type	Receives
All patients	Experimental	Behavioral: Virtual Reality Session (VR Blu), Behavioral: Tablet-based Session (Tablet Blu), Behavioral: Use of Virtual Reality Head Mounted Display without Content (VR Blank)All patients were intended to engage in three different 20-30 min sessions run by research coordinators and spaced a minimum of 4 hours apart to allow for washout of effects, including 1) a commercially available, immersive VR environment, theBlu (WEVR, Inc, Venice, California, USA) delivered via Oculus Rift (Oculus VR, Irvine, California, USA) headset (VR Blu), 2) a non-immersive two-dimensional mimic delivered via a tablet computer (Tablet Blu), and 3) a VR control session delivered via a content-less Oculus Rift headset (VR Blank). The three sessions were run by research coordinators and spaced a minimum of 4 hours apart. The intervention order was counterbalanced using a randomized sequence generator.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of Traumatic Injury (including but not limited to traumatic brain injury)
Age greater than or equal to 18 years-old
Endorsing at least moderate pain as defined by documentation of at least one numeric rating pain scale score of 3 or more in the last 24 hours.
Glasgow Coma Scale of 15
Expected to stay in the hospital for at least 12 hours after enrollment

Key exclusion criteria (5 listed)

Seizure prior to enrollment
Pregnancy
non-English speaking
Known intolerance of Virtual Reality
Patient unable to consent for themselves

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 Session (VR Blu)20-30 minute session of virtual reality immersive content.	Behavioural	All patients
Tablet-based Session (Tablet Blu)20-30 minute session of tablet-based content that mimics the content from virtual reality sessions.	Behavioural	All patients
Use of Virtual Reality Head Mounted Display without Content (VR Blank)20-30 minutes session using head mounted display to reduce light and sound.	Behavioural	All patients

Primary outcome

Change in Pain Score
Time frame: Pre- and Post-Intervention (approximately 30 minutes)
Pre- vs. Post-Intervention Ratings on Numeric Pain Rating Scale. Numeric Pain Rating scale range is from 0 (no pain) -10 (severe pain)

1 secondary outcome

Opioid Administration
Time frame: 4 hours post-intervention vs. 4 hours pre-intervention

Results and safety

Results posted to the registry on 24 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Patients	60	59

Primary outcome: Change in Pain Score

Time frame: Pre- and Post-Intervention (approximately 30 minutes). Mean (Standard Error). Unit: score on a scale

Measure	All Patients n = 59
VR Blu Intervention Pain Reduction	-0.92 (0.33)
Tablet Blu Intervention Pain Reduction	-0.16 (0.29)
VR Blank Intervention Pain Reduction	-1.24 (0.33)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Duration of Study Involvement (typically < 48 hours). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 54 (0%)	0 of 54 (0%)	0 of 54

Limitations and caveats (from the sponsor): Very few patients with TBI met inclusion criteria. The intervals between conditions were quite short to improve feasibility of study completion based on brief anticipated length of stay. This limited our ability to evaluate effects on opioid use and duration of VR intervention effect. The sample size limited our ability to account for multiple comparisons.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37079851Morris NA, Wang Y, Felix RB, Rao A, Arnold S, Khalid M, Armahizer MJ, Murthi SB, Colloca L. Adjunctive virtual reality pain relief after traumatic injury: a proof-of-concept within-person randomized trial. Pain. 2023 Sep 1;164(9):2122-2129. doi: 10.1097/j.pain.0000000000002914. Epub 2023 Apr 19.
Derived from this study: PubMed 34848527Felix RB, Rao A, Khalid M, Wang Y, Colloca L, Murthi SB, Morris NA. Adjunctive virtual reality pain relief following traumatic injury: protocol for a randomised within-subjects clinical trial. BMJ Open. 2021 Nov 30;11(11):e056030. doi: 10.1136/bmjopen-2021-056030.
Individual participant dataSharing planned: No

Related trials for Traumatic Brain Injury

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma

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.

Nicholas A Morris, M.D. principal investigator

University of Maryland, Baltimore

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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: finished, as of the sponsor's last update on 24 Apr 2023. 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. 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 24 Apr 2023). 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?

Change in Pain Score (time frame: Pre- and Post-Intervention (approximately 30 minutes)). 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 NCT04356963, which also lists 2 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 24 Apr 2023.