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NCT Number: NCT05728840

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Lausanne Hospitals

Lausanne, 1015, Switzerland

Location status: Recruiting

Location contact

Sonia Crottaz-Herbette

CONTACT

[email protected]

+41213149348

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immersive virtual reality gamified cognitive activities

Other

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 activities

Other

This intervention will include 20 sessions of training using a standard neuropsychological rehabilitation program, in addition to the standard of care.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. User Engagement Scale (UES)

    Time frame: After 20 days of training (end of intervention)

  16. NASA task load index (NASA-TLX)

    Time frame: After 20 days of training (end of intervention)

Study contacts

Contact information is provided by the study sponsor or research team.

Sonia Crottaz-Herbette

CONTACT

[email protected]

+41213149348

Sponsors and collaborators

Lead sponsor

Mindmaze SA

Industry

Collaborators

  • University of Lausanne Hospitals

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 15, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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