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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
135
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.
This intervention will include 20 sessions of training using a standard neuropsychological rehabilitation program, in addition to the standard of care.
University of Lausanne Hospitals
Lausanne, Switzerland
RECRUITINGChange from baseline in Test of Attentional Performance (TAP)
Main deficit of Attention
Time frame: Before the intervention (baseline) and after 20 days of training (end of intervention), within 7 weeks from first day of training
Test of Attentional Performance (TAP)
Main deficit of Attention
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: After 20 days of training (end of intervention)
NASA task load index (NASA-TLX)
Time frame: After 20 days of training (end of intervention)
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