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

February 13, 2026 updated by: Mindmaze SA
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Before the intervention (baseline) and after 20 days of training (end of intervention), within 7 weeks from first day of training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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)
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
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)
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
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
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
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
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
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
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
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
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
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
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
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)
After 20 days of training (end of intervention)
NASA task load index (NASA-TLX)
Time Frame: After 20 days of training (end of intervention)
After 20 days of training (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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mindmaze SA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Lausanne Hospitals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sonia Crottaz-Herbette, University of Lausanne Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings