Virtual-reality Exercises for Alleviating Attention Deficits in Patients With Acquired Brain Injury

Study Overview
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Brief Summary
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Stroke is the leading cause of long-term disability with an increasing incidence, especially in young adults. Among the cognitive difficulties following brain damage, deficits in attention are frequent and pervasive, affecting between 46% and 92% of stroke survivors. The current project targets patients with acquired brain injury, including stroke, traumatic brain injury, and brain tumor. The main objective of this study is to evaluate the use and the efficacy of a training program targeting attention and executive function difficulties, using gamified and digitized versions in virtual reality of standard cognitive exercises for patients with brain lesions.

Detailed Description
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Among the cognitive disorders due to stroke, attention impairments are frequent and pervading deficits with a variable incidence ranging from 46% to 92% for attention deficits. Stroke patients may have difficulties to focus, pay attention or attend to more than one stimulus at a time. These deficits are insufficiently addressed in the current standard of care. The proposed study is a three-arm (N=45 per group), double-blind, randomized, and actively controlled study. This study uses immersive virtual reality (VR) based training protocols to address attention and executive dysfunctions in patients with stroke. For each cognitive domain, the solution proposes specific gamified activities, with different levels of difficulty, titrated to the patient's level of impairment, assessed by embedded short assessments. The investigators hypothesize that a daily training using VR-based gamified neuropsychological activities, in addition to standard of care, will decrease attention and executive deficits as much as time-matched daily extra neuropsychological sessions of standard of care. The investigators hypothesize too that delivering such daily extra session of VR-based gamified neuropsychological activities in addition to the standard of care will decrease more attention deficits than the actual regular standard of care dose. The primary outcome will be the change in attentional abilities, measured by standardized tests of attention, before and after 20 sessions of VR-based training for the experimental group and 20 additional neuropsychological are sessions for the dose-match control group. The secondary outcomes will include changes in spatial cognition, attention in activities of daily life, executive functions, influence of the lesions' etiology, impression of our rehabilitation program as a credible treatment, among others.

Official Title
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Virtual-reality Exercises for Alleviating Attention Deficits in Patients With Acquired Brain Injury

Conditions
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Stroke, Attention Disorder

Intervention / Treatment
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* Other: Immersive virtual reality gamified cognitive activities
* Other: Double neuropsychological standard activities


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Time from stroke onset < 1 month Objective pathological performance on at least one standardized test or subtest on attention during standard neuropsychological evaluation Brain injury documented by routine neuroradiological examination (computed tomography or magnetic resonance imaging scan) Able to give informed consent as documented by signature Age >= 18 years old Exclusion Criteria: Epilepsy Inability or contraindications to undergo the investigated intervention Major psychiatric co-morbidity Major neurocognitive deficits (e.g. dementia) Incapacity to discriminate colors General cognitive state preventing to understand and perform the tasks Decision to not be informed of incidental findings

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation intervention group<br>Each participant of the experimental group will undergo an initial cognitive screening (pre-training) and, in addition to their standard of care, they will have 20 additional sessions with the experimental rehabilitation program. Post-treatment cognitive screening will be completed at the end of the program, then 3-4 and 6-12 months later. | Other: Immersive virtual reality gamified cognitive activities<br>* This intervention will include 20 sessions of training with the experimental rehabilitation program using immersive VR cognitive gamified activities, in addition to the standard of care.<br>|
| Active Comparator: Dose-match control group<br>Each participant of the experimental group will undergo an initial cognitive screening (pre-training) and, in addition to their standard of care, they will have 20 additional sessions of neuropsychological standard sessions. Post-treatment cognitive screening will be completed at the end of the program, then 3-4 and 6-12 months later. | Other: Double neuropsychological standard activities<br>* This intervention will include 20 sessions of training using a standard neuropsychological rehabilitation program, in addition to the standard of care.<br>|
| No Intervention: Retrospective standard of care group<br>Each participant of the retrospective group will be included retrospectively if they were hospitalized in the study's sites between 2012 and 2022, and followed standard neuropsychological rehabilitation of attention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Test of Attentional Performance (TAP) | Main deficit of Attention | Before the intervention (baseline) and after 20 days of training (end of intervention), within 7 weeks from first day of training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test of Attentional Performance (TAP) | Main deficit of Attention | Before the intervention (baseline), after 10 days of training (mid-training), 3-4 and 6-12 months after the end of intervention | 
| Test of Attentional Performance (TAP) | Other deficits of attention | Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention | 
| Wechsler Memory Scale (WMS-III) |  | Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention | 
| Brief Visuospatial Memory Test (BVMT) |  | Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention | 
| Stroop test |  | Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention | 
| Rating Scale of Attentional Behaviour (RSAB) |  | Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention | 
| Catherine Bergego Scale (CBS) |  | Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention | 
| Stroke impact Scale (SIS) |  | Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention | 
| Far space attention: Hemineglect far space Immersive VR-based task |  | Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention | 
| Response to saliency: Immersive VR-based free-viewing exploration (FVE-VR) task |  | Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention | 
| Credibility/Expectancy Questionnaire (CEQ) |  | Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention | 
| Fatigue: Penner questionnaire |  | Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention | 
| Immersive VR-based attentional performance task |  | Before the intervention (baseline), after each cycle of 5 days of training, after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention | 
| Defense Automated Neurobehavioral Assessment (DANA) |  | Before the intervention (baseline), after each cycle of 5 days of training, after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention | 
| User Engagement Scale (UES) |  | After 20 days of training (end of intervention) | 
| NASA task load index (NASA-TLX) |  | After 20 days of training (end of intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, attention, executive functions, virtual reality, neurorehabilitation