Virtual-reality Exercises for Alleviating Attention Deficits in Patients With Acquired Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMindmaze SA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Epilepsy
Inability or contraindications to undergo the investigated intervention
Major psychiatric co-morbidity
Major neurocognitive deficits (e.g. dementia)
Trial design
Design model
Parallel
Treatments tested in this trial
Immersive virtual reality gamified cognitive activities
Other interventionThis 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.
Double neuropsychological standard activities
Other interventionThis intervention will include 20 sessions of training using a standard neuropsychological rehabilitation program, in addition to the standard of care.
Treatment groups
135 Participants
are divided into 3 treatment groupsGroup A: Rehabilitation intervention groupExperimental treatment 1 intervention
Group B: Dose-match control groupActive comparator 1 intervention
Group C: Retrospective standard of care groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change 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 trainingSecondary outcomes
1
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 intervention2
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 intervention3
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 intervention4
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 interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mindmaze SA
Lead sponsor
University of Lausanne Hospitals
Collaborator
Source ClinicalTrials.gov