Traumatic Brain InjuryNCT05443542
VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI
A study testing Virtual Reality in people with Traumatic Brain Injury and Stroke, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
Trial summary
One hundred participants with acquired brain injury (ABI) will be included in a randomized controlled trial, with one group playing a commercially available VR game and the control group doing activities in their everyday as cognitive training. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury, Stroke, Acquired Brain Injury
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 15 Sep 2022to Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in stable phase after Acquired brain injury, minimum one year after injury
- Physically able to operate VR-technology
- Norwegian or English skills adequate to understand instructions, play the VR-games and to provide valid responses to assessment methods
Who cannot join
- Severe aphasia affecting their understanding of instructions
- Apraxia affecting their ability to use VR-equipment
- Visual neglect
- Severe mental illness, substance abuse or co-existing neurological disorders
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Sunnaas Rehabilitation Hospital
Nesoddtangen, Akershus, 1453
Anne Catrine Trægde Martinsen, PhD, anne.catrine.traegde.martinsen@sunnaas.no
About this study
Official title: Virtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With Acquired Brain Injury
One hundred participants with acquired brain injury (ABI) will be included in a randomized controlled trial, with one group playing a commercially available VR game and the control group doing activities in their everyday as cognitive training. The trial aims to investigate how VR can affect processing speed in the ABI population, and if these effects can transfer into everyday activities. The training will be performed in the participants homes, with assistance provided by the project group via phone or video conference. The training period will last five weeks. Participant's cognitive functions will be measured with questionnaires and neuropsychological tests at the start of the training period, at the end of training and sixteen weeks after the start of the intervention. In depth experiences with VR as a training method will be gathered through performing focus group interviews with some of the participants from the VR group, in addition to self-reported questionnaires from all the participants.
Read the detailed description
A randomized controlled trial (RCT) will be conducted where the experimental intervention is playing a commercial VR game. The VR group will follow a training regime of a 30 min VR session five times per week for 5 weeks. The control group will carry on with treatment as usual, in addition, participants will receive an information booklet covering cognitive training in everyday life. Baseline and outcome measures in terms of neuropsychological assessment and questionnaires will be performed at baseline (T1), at the end of the intervention period (T2) and at the 16-week follow-up (T3).
The VR group will train with a rhythm VR game that is considered as a good candidate for basic training of the multifaceted aspects of attention including speed of information processing, selection, sustained attention, shifting/dividing of attention, and working memory.
The VR game is selected on the grounds of clinical experience with VR training of processing speed, attention and working memory, and is also suggested in research as suitable games for cognitive rehabilitation.
- Being tested
- Virtual Reality, Control intervention
- Keywords
- TBI, Traumatic brain injury, Stroke, Acquired brain injury, Virtual Reality, VR, Cognitive rehabilitation
- Medical subject headings
- Brain Injuries, Traumatic, Stroke, Brain Injuries, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Also called Oculus Quest 2
Game to be played is a commercially available VR game
Control interventionOther
Sodoku, crossword puzzles
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Group 1 will play a VR game using an Oculus Quest 2 in a home setting Receives: Device: Virtual Reality |
| Active control group | Active comparator | The control group will be given a pamphlet containing exercises affecting working memory, attention and processing speed to be performed in a home setting Receives: Other: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in processing speed
Connors Continous Performance test 3rd edition, Coefficient of Variation
Measured: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Secondary outcomes (6)
Change in patient reported executive functioning
Behavior Rating Inventory of Executive function (BRIEF-A)
Measured: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Transfer effect to everyday activities
Patient Competency Rating Scale
Measured: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Change in working memory
Wechslers Adult Intelligence Scale IV, Backwards Digit Span
Measured: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Change in working memory
Wechslers Adult Intelligence Scale IV, Digit sequencing test
Measured: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Change in informant reported executive functioning
Behavior Rating Inventory of Executive function (BRIEF-A)
Measured: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Change in sustained attention
Connors Continous Performance test 3rd edition, Performance variability over time
Measured: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start15 Sep 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnaas Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo Metropolitan University, Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Marianne Løvstad, PhD, Principal investigator, Sunnaas Rehabilitation hopsital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443542
- Sponsor's protocol ID
- VR i kogn rehab av tempo
- Status last verified
- Nov 2022
- First submitted
- 19 May 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be deidentified and will not be made publicly available due to data protection regulations
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT05443542
- Acronym / sponsor ID
- VR i kogn rehab av tempo
- Keywords
- TBI, Traumatic brain injury, Stroke, Acquired brain injury, Virtual Reality, VR, Cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sunnaas Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Oslo Metropolitan University, Norwegian University of Science and Technology
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Jul 2022 (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.
One hundred participants with acquired brain injury (ABI) will be included in a randomized controlled trial, with one group playing a commercially available VR game and the control group doing activities in their everyday as cognitive training. The trial aims to investigate how VR can affect processing speed in the ABI population, and if these effects can transfer into everyday activities. The training will be performed in the participants homes, with assistance provided by the project group via phone or video conference. The training period will last five weeks. Participant's cognitive functions will be measured with questionnaires and neuropsychological tests at the start of the training period, at the end of training and sixteen weeks after the start of the intervention. In depth experiences with VR as a training method will be gathered through performing focus group interviews with some of the participants from the VR group, in addition to self-reported questionnaires from all the participants.
Detailed description
A randomized controlled trial (RCT) will be conducted where the experimental intervention is playing a commercial VR game. The VR group will follow a training regime of a 30 min VR session five times per week for 5 weeks. The control group will carry on with treatment as usual, in addition, participants will receive an information booklet covering cognitive training in everyday life. Baseline and outcome measures in terms of neuropsychological assessment and questionnaires will be performed at baseline (T1), at the end of the intervention period (T2) and at the 16-week follow-up (T3).
The VR group will train with a rhythm VR game that is considered as a good candidate for basic training of the multifaceted aspects of attention including speed of information processing, selection, sustained attention, shifting/dividing of attention, and working memory.
The VR game is selected on the grounds of clinical experience with VR training of processing speed, attention and working memory, and is also suggested in research as suitable games for cognitive rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Virtual RealityGroup 1 will play a VR game using an Oculus Quest 2 in a home setting |
| Active control group | Active comparator | Other: Control interventionThe control group will be given a pamphlet containing exercises affecting working memory, attention and processing speed to be performed in a home setting |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients in stable phase after Acquired brain injury, minimum one year after injury
- Physically able to operate VR-technology
- Norwegian or English skills adequate to understand instructions, play the VR-games and to provide valid responses to assessment methods
Key exclusion criteria (4 listed)
- Severe aphasia affecting their understanding of instructions
- Apraxia affecting their ability to use VR-equipment
- Visual neglect
- Severe mental illness, substance abuse or co-existing neurological disorders
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 RealityAlso: Oculus Quest 2Game to be played is a commercially available VR game | Device | Virtual Reality Group |
| Control interventionSodoku, crossword puzzles | Other | Active control group |
Primary outcome
Change in processing speed
Time frame: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Connors Continous Performance test 3rd edition, Coefficient of Variation
6 secondary outcomes
Change in patient reported executive functioning
Time frame: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Transfer effect to everyday activities
Time frame: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Change in working memory
Time frame: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Change in working memory
Time frame: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Change in informant reported executive functioning
Time frame: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Change in sustained attention
Time frame: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No. Data will be deidentified and will not be made publicly available due to data protection regulations
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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.
Marianne Løvstad, PhD principal investigator
Sunnaas Rehabilitation hopsital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Traumatic Brain Injury and Stroke, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
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 3 inclusion and 4 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 8 Nov 2022. 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 Norway. 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 Marianne Løvstad, PhD (+4793452003, marianne.lovstad@sunnaas.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in processing speed (time frame: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)). 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 8 Nov 2022.