Attention Disorder, Stroke
Conditions
Keywords
stroke, attention, executive functions, virtual reality, neurorehabilitation
Brief summary
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
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.
Interventions
OTHERImmersive virtual reality gamified cognitive activities
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.
OTHERDouble neuropsychological standard activities
This intervention will include 20 sessions of training using a standard neuropsychological rehabilitation program, in addition to the standard of care.
Sponsors
Mindmaze SA
University of Lausanne Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Test of Attentional Performance (TAP) | Before the intervention (baseline) and after 20 days of training (end of intervention), within 7 weeks from first day of training | Main deficit of Attention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Test of Attentional Performance (TAP) | Before the intervention (baseline), after 10 days of training (mid-training), 3-4 and 6-12 months after the end of intervention | Main deficit of Attention |
| 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) | — |
Countries
Switzerland
Contacts
CONTACTSonia Crottaz-Herbette
PRINCIPAL_INVESTIGATORSonia Crottaz-Herbette
University of Lausanne Hospitals
Outcome results
None listed