Virtual-reality Exercises for Alleviating Attention Deficits in Patients With Acquired Brain Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immersive virtual reality gamified cognitive activities, Double neuropsychological standard activities.
- Who it may be relevant to
- Registry conditions: Stroke, Attention Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other Immersive 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. - Other Double neuropsychological standard activities
This intervention will include 20 sessions of training using a standard neuropsychological rehabilitation program, in addition to the standard of care.
Primary outcome measures
- Change from baseline in Test of Attentional Performance (TAP) [Time frame: Before the intervention (baseline) and after 20 days of training (end of intervention), within 7 weeks from first day of training]
Secondary outcome measures (12)
- Test of Attentional Performance (TAP) [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) [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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- University of Lausanne Hospitals — Lausanne
Identifiers
NCT: NCT05728840 · MFOCUS-1