TBINCT05309005
Virtual Reality and Social Cognition After Acquired Brain Injury
An observational study of TBI and Stroke, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
Trial summary
The study aim is to improve assessment and understanding of social cognitive impairment after acquired brain injury by developing and validating a virtual reality version of The Awareness of Social Inference Test (TASIT). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- TBI, Stroke, Acquired Brain Injury
- What is being tested?
- VR TASIT and DT TASIT
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 15 Sep 2022to Dec 2024
- Phase
- Observational
- 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
Study population: Acquired Brain Injury
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 skills adequate to understand instructions and dialogues in TASIT videos.
Who cannot join
- Severe aphasia affecting their understanding of instructions
- Apraxia affecting their ability to use VR-equipment
- Visual neglect
- Severe mental illness 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
The study aim is to improve assessment and understanding of social cognitive impairment after acquired brain injury by developing and validating a virtual reality version of The Awareness of Social Inference Test (TASIT). It is expected that the VR version of the test has comparable or better psychometric properties than the video version, and that it has improved relevance to everyday social skills. It is also expected that the VR version taxes cognitive functions more than a desktop version with identical content as the VR version.
Read the detailed description
The study's main aim is to validate a Norwegian virtual reality (VR) adaptation of The Awareness of Social Inference Test (TASIT) in an acquired brain injury population (ABI). The secondary aim is to increase our understanding of the interplay between social cognition and general cognition in a realistic social setting, i.e. an immersive virtual environment.
TASIT is one of the few available standardized tests of social cognition with good and documented norms and psychometric properties. The original TASIT consists of three subtests, one subtest measuring emotion recognition and two subtests measuring Theory of Mind. It has an A and a B form for retest purposes. Each subtest consists of short videos depicting various social scenes. The participant's task is to identify a character's emotions, beliefs or intentions, depending on the subtest. TASIT predicts social cognitive impairments in several patient groups, including ABI.
VR is an immersive, computer-generated three-dimensional environment. Computer- and behavioral interfaces are used to simulate the behavior of 3D entities that interact in real time with a user who is immersed in the virtual environment. VR facilitates a sense of social presence, i.e. a feeling of being part of social situations, not attainable in a two-dimensional medium. Assessing social cognition in a virtual environment with higher social presence could increase the test's ecological validity.
For the Norwegian version of TASIT the manuscripts from all videos from the A form were translated into Norwegian. The original dialogues and plot lines from the original test were retained, except minor adaptations for modernization purposes and to exploit the potential for social presence in VR. The scenes were filmed with a 360-degree camera, allowing production of one immersive three-dimensional VR version (VR TASIT) and a standard, two-dimensional desktop version (DT TASIT). The versions are otherwise identical.
Research Questions: The overall aim is to improve assessment and understanding of social cognitive impairment in patients with ABI. This will be done by investigating the psychometric properties and validity of a VR version of TASIT.
The primary research question is:
- What is the construct validity (known groups validity, convergent and divergent validity) and test-retest reliability of a Norwegian VR version of TASIT (VR TASIT), and are the psychometric properties comparable or improved compared to the original test? Secondary research questions are:
- Does the VR version of TASIT contribute to increased ecological validity in assessment of social cognition?
- Does the application of VR TASIT result in increased cognitive load compared to the 2D version, and thus in higher correlations with tests of processing speed, attention, abstract thinking and executive functioning?
- Conditions
- TBI, Stroke, Acquired Brain Injury, Brain Injuries
- Being tested
- VR TASIT, DT TASIT
- Keywords
- Virtual Reality, VR, Social cognition, Emotion recognition, Theory of Mind, Assessment, Ecological validity, TBI, Stroke, Acquired Brain Injury
- Medical subject headings
- Stroke, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR TASITBehavioural
Consists of a Norwegian adaptation of the 59 videos of social scenes that constitute the A Form in the original TASIT. The stimulus material in the Virtual Reality version is perceived through a head mounted display. This allows the test person to watch the scenes in three dimensions and a 360 degree angle, increasing the sense of social presence.
DT TASITBehavioural
Consists of a Norwegian adaptation of the 59 videos of social scenes that constitute the A Form in the original TASIT, with identical content as the VR TASIT. The stimulus material in the desktop version is perceived on a two dimensional desktop computer screen.
| Study group | Role | What they receive |
|---|---|---|
| ABI group | The patient group consists of 100 patients with acquired brain injury (e.g. cerebrovascular incidents, anoxia, encephalitis and non-progressive brain tumors) Receives: Behavioral: VR TASIT; Behavioral: DT TASIT | |
| Healthy control group | 100 healthy adults will be matched to the patients with respect to age, gender and education. Receives: Behavioral: VR TASIT; Behavioral: DT TASIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Known Groups Validity of VR TASIT assessed with Mann Whitney U test
It is expected that the patient group performs poorer than the control group on the VR TASIT, both total score and scores on each of the three subtests.
Measured: 60 minutes
Reliability of VR TASIT in the patient group assessed with paired sample t-tests
The test-retest reliability of VR TASIT in the patient group is determined by re-administering the test 16 weeks after the first administration and calculating the correlation. Analysis of both total score and subscores will be conducted.
Measured: 60 minutes
Secondary outcomes (3)
Convergent Validity of VR TASIT in the patient group assessed with paired sample t-tests.
It is expected that performance on the VR TASIT correlates with performance on three established tests of social cognition, the Hinting Task, the Emotion Recognition Task, and the Interpersonal Reactivity Index.
The Hinting Task is a measure of Theory of Mind that assesses understanding of people's intentions from indirect messages. The task consists of 10 text vignettes of a protagonist expressing an indirect message to another person. Participants are asked to describe the meaning behind the indirect messages.
The Emotion Recognition Task (ERT) measures emotion recognition by asking participants to label facial expressions from photographs.
The Interpersonal Reactivity Index (IRI) is a measure of empathy, designed to distinguish persons who experience more of the feelings of others from those who are less responsive to the emotional expressions and experiences of others. It contains 28 items that participants answer on a five-point Likert-type scale.
Measured: 60 minutes
Divergent Validity of VR TASIT in the patient group assessed with paired sample t-tests.
Weak to moderate associations between VR-TASIT and measures of mental efficiency, working memory, abstraction and executive functions.
Mental efficiency is assessed with Conners Continuous Performance Test III - Mean Hit Reaction Time.
Working Memory is assessed with a composite score consisting of Digit Span Backward and Digit Span Sequencing from the Wechsler Adult Intelligence Scale IV.
Abstraction is assessed with a composite score consisting of Similarities and Matrices from the Wechsler Adult Intelligence Scale IV.
Three executive functions are assessed: mental flexibility, interference inhibition and sustained attention. Mental flexibility is measured with with Trail Making Test 4 from Delis-Kaplan Executive Function System, interference inhibition is measured with Color Word Interference Test 3 from Delis-Kaplan Executive Function System and sustained attention is measured with Standard deviation of Hit Reaction time from Conners Continuous Performance Test III.
Measured: 60 minutes
Ecological Validity of VR TASIT assessed with paired sample t-tests.
It is expected that performance on the VR TASIT correlates with self-reported everyday social functioning, assessed with the La Trobe Communication Questionnaire (LCQ). LCQ measures impairments in social communication with 30 items rated by patients and informants. The LCQ has been translated into Norwegian and discriminates between people with brain injury and healthy adults.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 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 TBIStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnaas Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Marianne Løvstad, Professor, Principal investigator, Sunnaas Rehabilitation Hospital and University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309005
- Sponsor's protocol ID
- Sosial kognisjon
- Status last verified
- Nov 2022
- First submitted
- 24 Mar 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality and Social Cognition After Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT05309005
- Acronym / sponsor ID
- Sosial kognisjon
- Conditions
- TBI, Stroke, Acquired Brain Injury, Brain Injuries
- Keywords
- Virtual Reality, VR, Social cognition, Emotion recognition, Theory of Mind, Assessment, Ecological validity, TBI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sunnaas Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 4 Apr 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.
The study aim is to improve assessment and understanding of social cognitive impairment after acquired brain injury by developing and validating a virtual reality version of The Awareness of Social Inference Test (TASIT). It is expected that the VR version of the test has comparable or better psychometric properties than the video version, and that it has improved relevance to everyday social skills. It is also expected that the VR version taxes cognitive functions more than a desktop version with identical content as the VR version.
Detailed description
The study's main aim is to validate a Norwegian virtual reality (VR) adaptation of The Awareness of Social Inference Test (TASIT) in an acquired brain injury population (ABI). The secondary aim is to increase our understanding of the interplay between social cognition and general cognition in a realistic social setting, i.e. an immersive virtual environment.
TASIT is one of the few available standardized tests of social cognition with good and documented norms and psychometric properties. The original TASIT consists of three subtests, one subtest measuring emotion recognition and two subtests measuring Theory of Mind. It has an A and a B form for retest purposes. Each subtest consists of short videos depicting various social scenes. The participant's task is to identify a character's emotions, beliefs or intentions, depending on the subtest. TASIT predicts social cognitive impairments in several patient groups, including ABI.
VR is an immersive, computer-generated three-dimensional environment. Computer- and behavioral interfaces are used to simulate the behavior of 3D entities that interact in real time with a user who is immersed in the virtual environment. VR facilitates a sense of social presence, i.e. a feeling of being part of social situations, not attainable in a two-dimensional medium. Assessing social cognition in a virtual environment with higher social presence could increase the test's ecological validity.
For the Norwegian version of TASIT the manuscripts from all videos from the A form were translated into Norwegian. The original dialogues and plot lines from the original test were retained, except minor adaptations for modernization purposes and to exploit the potential for social presence in VR. The scenes were filmed with a 360-degree camera, allowing production of one immersive three-dimensional VR version (VR TASIT) and a standard, two-dimensional desktop version (DT TASIT). The versions are otherwise identical.
Research Questions: The overall aim is to improve assessment and understanding of social cognitive impairment in patients with ABI. This will be done by investigating the psychometric properties and validity of a VR version of TASIT.
The primary research question is:
- What is the construct validity (known groups validity, convergent and divergent validity) and test-retest reliability of a Norwegian VR version of TASIT (VR TASIT), and are the psychometric properties comparable or improved compared to the original test? Secondary research questions are:
- Does the VR version of TASIT contribute to increased ecological validity in assessment of social cognition?
- Does the application of VR TASIT result in increased cognitive load compared to the 2D version, and thus in higher correlations with tests of processing speed, attention, abstract thinking and executive functioning?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABI group | – | Behavioral: VR TASIT, Behavioral: DT TASITThe patient group consists of 100 patients with acquired brain injury (e.g. cerebrovascular incidents, anoxia, encephalitis and non-progressive brain tumors) |
| Healthy control group | – | Behavioral: VR TASIT, Behavioral: DT TASIT100 healthy adults will be matched to the patients with respect to age, gender and education. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acquired Brain Injury
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 skills adequate to understand instructions and dialogues in TASIT videos.
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 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 |
|---|---|---|
| VR TASITConsists of a Norwegian adaptation of the 59 videos of social scenes that constitute the A Form in the original TASIT. The stimulus material in the Virtual Reality version is perceived through a head mounted display. This allows the test person to watch the scenes in three dimensions and a 360 degree angle, increasing the sense of social presence. | Behavioural | ABI group, Healthy control group |
| DT TASITConsists of a Norwegian adaptation of the 59 videos of social scenes that constitute the A Form in the original TASIT, with identical content as the VR TASIT. The stimulus material in the desktop version is perceived on a two dimensional desktop computer screen. | Behavioural | ABI group, Healthy control group |
Primary outcome
Known Groups Validity of VR TASIT assessed with Mann Whitney U test
Time frame: 60 minutes
It is expected that the patient group performs poorer than the control group on the VR TASIT, both total score and scores on each of the three subtests.
Reliability of VR TASIT in the patient group assessed with paired sample t-tests
Time frame: 60 minutes
The test-retest reliability of VR TASIT in the patient group is determined by re-administering the test 16 weeks after the first administration and calculating the correlation. Analysis of both total score and subscores will be conducted.
3 secondary outcomes
Convergent Validity of VR TASIT in the patient group assessed with paired sample t-tests.
Time frame: 60 minutes
Divergent Validity of VR TASIT in the patient group assessed with paired sample t-tests.
Time frame: 60 minutes
Ecological Validity of VR TASIT assessed with paired sample t-tests.
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
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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, Professor principal investigator
Sunnaas Rehabilitation Hospital and University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TBI 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 10 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, Professor (+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?
Known Groups Validity of VR TASIT assessed with Mann Whitney U test (time frame: 60 minutes). 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?
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 10 Nov 2022.