NCT05728840

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Mindmaze SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Attention Disorder

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-02-15
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2023-02-15
• Last updated: 2026-02-17

Locations

1 site across 1 country: Switzerland