Virtual-reality Exercises for Alleviating Attention Deficits in Patients With Acquired Brain Injury
Study Details
Study Description
Brief Summary
Stroke is the leading cause of long-term disability with an increasing incidence, especially in young adults. Among the cognitive difficulties following a 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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. Similarly, to stroke patients, patients with traumatic brain injury (TBI) and patients with brain tumors (before and/or after neurosurgery) 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 acquired brain injury. 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 and executive functions, 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, influence of the lesions' etiology, impression of our rehabilitation program as a credible treatment, among others.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rehabilitation intervention group 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
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.
|
| Active Comparator: Dose-match control group 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
This intervention will include 20 sessions of training using a standard neuropsychological rehabilitation program, in addition to the standard of care.
|
| No Intervention: Retrospective standard of care group 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 and/or executive functions. |
Outcome Measures
Primary Outcome Measures
- 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
- Change from baseline in Wechsler Memory Scale (WMS-III) [Before the intervention (baseline) and after 20 days of training (end of intervention), within 7 weeks from first day of training]
Secondary Outcome Measures
- 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 10 days of training (mid-training), 3-4 and 6-12 months after the end of intervention]
- Test of Attentional Performance (TAP) [Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention]
Other deficits of attention
- 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)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Time from stroke onset, brain trauma or diagnostic of brain tumor < 1 month
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Objective pathological performance on at least one standardized test or subtest on attention or executive functions during standard neuropsychological evaluation
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Brain injury documented by routine neuroradiological examination (computed tomography or magnetic resonance imaging scan)
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Able to give informed consent as documented by signature
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Age >= 18 years old
Exclusion Criteria:
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Epilepsy
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Inability or contraindications to undergo the investigated intervention
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Major psychiatric co-morbidity
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Major neurocognitive deficits (e.g. dementia)
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Incapacity to discriminate colors
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General cognitive state preventing to understand and perform the tasks
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Decision to not be informed of incidental findings
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Lausanne Hospitals | Lausanne | Switzerland | 1015 |
Sponsors and Collaborators
- Mindmaze SA
- University of Lausanne Hospitals
Investigators
- Principal Investigator: Sonia Crottaz-Herbette, University of Lausanne Hospitals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MFOCUS-1