Clinical trial NCT05728840: Virtual-reality Exercises for Alleviating Attention Deficits in Patients with Acquired Brain Injury
Official title: Virtual-reality Exercises for Alleviating Attention Deficits in Patients with Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Attention Disorder
Keywords: stroke
attention
executive functions
virtual reality
neurorehabilitation
Lead sponsor: Mindmaze SA
Sponsor class: INDUSTRY
Collaborators: name: University of Lausanne Hospitals
First posted: 2023-02-15
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in Test of Attentional Performance (TAP)
timeFrame: Before the intervention (baseline) and after 20 days of training (end of intervention), within 7 weeks from first day of training
Secondary outcomes:
measure: Test of Attentional Performance (TAP)
timeFrame: Before the intervention (baseline), after 10 days of training (mid-training), 3-4 and 6-12 months after the end of intervention
measure: Test of Attentional Performance (TAP)
timeFrame: Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention
measure: Wechsler Memory Scale (WMS-III)
timeFrame: Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention
measure: Brief Visuospatial Memory Test (BVMT)
timeFrame: Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention
measure: Stroop test
timeFrame: Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention
measure: Rating Scale of Attentional Behaviour (RSAB)
timeFrame: Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention
measure: Catherine Bergego Scale (CBS)
timeFrame: Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention
measure: Stroke impact Scale (SIS)
timeFrame: Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention
measure: Far space attention: Hemineglect far space Immersive VR-based task
timeFrame: Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention
measure: Response to saliency: Immersive VR-based free-viewing exploration (FVE-VR) task
timeFrame: Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention
measure: Credibility/Expectancy Questionnaire (CEQ)
timeFrame: Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention
measure: Fatigue: Penner questionnaire
timeFrame: Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention
measure: Immersive VR-based attentional performance task
timeFrame: 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
measure: Defense Automated Neurobehavioral Assessment (DANA)
timeFrame: 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
measure: User Engagement Scale (UES)
timeFrame: After 20 days of training (end of intervention)
measure: NASA task load index (NASA-TLX)
timeFrame: After 20 days of training (end of intervention)
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University of Lausanne Hospitals
Study officials:
affiliation: University of Lausanne Hospitals
name: Sonia Crottaz-Herbette
role: PRINCIPAL_INVESTIGATOR
References: