Virtual-reality Exercises for Alleviating Attention Deficits in Patients with Acquired Brain Injury

Not Applicable

Recruiting

• Conditions: Attention Disorder; Stroke
• Interventions: Other: Double neuropsychological standard activities; Other: Immersive virtual reality gamified cognitive activities

• Registration Number: NCT05728840
• Lead Sponsor: Mindmaze SA

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.

Study Timeline

• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-02-14
• Study Start: 2023-02-15
• Study First Posted: 2023-02-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2025-09-30
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose-match control group	Double neuropsychological standard activities	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.
Rehabilitation intervention group	Immersive virtual reality gamified cognitive activities	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.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
Wechsler Memory Scale (WMS-III)	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
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
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
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)
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
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

Trial Locations

Locations (1)

University of Lausanne Hospitals; 🇨🇭 Lausanne, Switzerland