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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Attention Disorder
• Intervention / Treatment: Other: Immersive virtual reality gamified cognitive activities; Other: Double neuropsychological standard activities

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 Type: Interventional
• Enrollment (Estimated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sonia Crottaz-Herbette; Phone Number: +41213149348; Email: sonia.crottaz-herbette@chuv.ch

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1015
    • Recruiting
    • University of Lausanne Hospitals
    • Contact: Sonia Crottaz-Herbette; Phone Number: +41213149348; Email: sonia.crottaz-herbette@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Test of Attentional Performance (TAP)	Main deficit of Attention	Before the intervention (baseline) and after 20 days of training (end of intervention), within 7 weeks from first day of training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test of Attentional Performance (TAP)	Main deficit of Attention	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)	Other deficits of attention	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)		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)
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

Collaborators and Investigators

• Sponsor: Mindmaze SA
• Collaborators: University of Lausanne Hospitals
• Investigators: Principal Investigator: Sonia Crottaz-Herbette, University of Lausanne Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: stroke; virtual reality; neurorehabilitation; attention; executive functions
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Neurocognitive Disorders; Stroke; Cognition Disorders
• Other Study ID Numbers: MFOCUS-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No