Clinical trial NCT05309005: Virtual Reality and Social Cognition After Acquired Brain Injury
Official title: Virtual Reality and Social Cognition After Acquired Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: TBI
Stroke
Acquired Brain Injury
Brain Injuries
Keywords: Virtual Reality
VR
Social cognition
Emotion recognition
Theory of Mind
Assessment
Ecological validity
TBI
Stroke
Acquired Brain Injury
Lead sponsor: Sunnaas Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2022-04-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acquired Brain Injury

Brief 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). 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:

1. 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:
2. Does the VR version of TASIT contribute to increased ecological validity in assessment of social cognition?
3. 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?

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Known Groups Validity of VR TASIT assessed with Mann Whitney U test
timeFrame: 60 minutes
measure: Reliability of VR TASIT in the patient group assessed with paired sample t-tests
timeFrame: 60 minutes
Secondary outcomes:
measure: Convergent Validity of VR TASIT in the patient group assessed with paired sample t-tests.
timeFrame: 60 minutes
measure: Divergent Validity of VR TASIT in the patient group assessed with paired sample t-tests.
timeFrame: 60 minutes
measure: Ecological Validity of VR TASIT assessed with paired sample t-tests.
timeFrame: 60 minutes
Other outcomes:
measure: Secondary Ecological Validity of VR TASIT assessed with paired sample t-tests.
timeFrame: 60 min
measure: Presence of VR TASIT versus DT TASIT in patient group assessed with paired sample t-test
timeFrame: 60 minutes
Locations:
city: Nesoddtangen
country: Norway
facility: Sunnaas Rehabilitation Hospital
state: Viken
Study officials:
affiliation: Sunnaas Rehabilitation Hospital and University of Oslo
name: Marianne Løvstad, Professor
role: PRINCIPAL_INVESTIGATOR
References: