StrokeNCT05728840
Virtual-reality Exercises for Alleviating Attention Deficits in Patients With Acquired Brain Injury
A study testing Immersive virtual reality gamified cognitive activities and Double neuropsychological standard activities in people with Stroke and Attention Disorder, run by Mindmaze SA at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Attention Disorder
- What is being tested?
- Immersive virtual reality gamified cognitive activities and Double neuropsychological standard activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Feb 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Lausanne Hospitals
Lausanne, 1015
Sonia Crottaz-Herbette, +41213149348, sonia.crottaz-herbette@chuv.ch
About this study
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.
Read the 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.
- Conditions
- Stroke, Attention Disorder
- Being tested
- Immersive virtual reality gamified cognitive activities, Double neuropsychological standard activities
- Keywords
- stroke, attention, executive functions, virtual reality, neurorehabilitation
- Medical subject headings
- Stroke, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive virtual reality gamified cognitive activitiesOther
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.
Double neuropsychological standard activitiesOther
This intervention will include 20 sessions of training using a standard neuropsychological rehabilitation program, in addition to the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation intervention group | Experimental | 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. Receives: Other: Immersive virtual reality gamified cognitive activities |
| Dose-match control group | Active comparator | 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. Receives: Other: Double neuropsychological standard activities |
| Retrospective standard of care group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Test of Attentional Performance (TAP)
Main deficit of Attention
Measured: Before the intervention (baseline) and after 20 days of training (end of intervention), within 7 weeks from first day of training
Secondary outcomes (16)
Test of Attentional Performance (TAP)
Main deficit of Attention
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: After 20 days of training (end of intervention)
NASA task load index (NASA-TLX)
Measured: After 20 days of training (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start15 Feb 2023
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mindmaze SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Sponsor
- Investigators
- Sonia Crottaz-Herbette, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728840
- Sponsor's protocol ID
- MFOCUS-1
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual-reality Exercises for Alleviating Attention Deficits in Patients With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT05728840
- Acronym / sponsor ID
- MFOCUS-1
- Conditions
- Stroke, Attention Disorder
- Keywords
- stroke, attention, executive functions, virtual reality, neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Mindmaze SAIndustry (pharma, biotech, devices)
- Collaborators
- University of Lausanne Hospitals
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation intervention group | Experimental | Other: Immersive virtual reality gamified cognitive activitiesEach 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. |
| Dose-match control group | Active comparator | Other: Double neuropsychological standard activitiesEach 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. |
| Retrospective standard of care group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Epilepsy
- Inability or contraindications to undergo the investigated intervention
- Major psychiatric co-morbidity
- Major neurocognitive deficits (e.g. dementia)
- Incapacity to discriminate colors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive virtual reality gamified cognitive activitiesThis 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. | Other | Rehabilitation intervention group |
| Double neuropsychological standard activitiesThis intervention will include 20 sessions of training using a standard neuropsychological rehabilitation program, in addition to the standard of care. | Other | Dose-match control group |
Primary outcome
Change from baseline in Test of Attentional Performance (TAP)
Time frame: 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
16 secondary outcomes
Test of Attentional Performance (TAP)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: After 20 days of training (end of intervention)
NASA task load index (NASA-TLX)
Time frame: After 20 days of training (end of intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sonia Crottaz-Herbette principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive virtual reality gamified cognitive activities and Double neuropsychological standard activities in people with Stroke and Attention Disorder, run by Mindmaze SA at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonia Crottaz-Herbette (+41213149348, sonia.crottaz-herbette@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Test of Attentional Performance (TAP) (time frame: Before the intervention (baseline) and after 20 days of training (end of intervention), within 7 weeks from first day of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.