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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05728840
• Other study ID #: MFOCUS-1
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: April 2023
• Source: Mindmaze SA
• Contact: Sonia Crottaz-Herbette
• Phone: +41213149348
• Email: sonia.crottaz-herbette[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: January 31, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Attention Disorder
• Brain Injuries
• Cognition Disorders
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	University of Lausanne Hospitals	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
Mindmaze SA	University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	User Engagement Scale (UES)		After 20 days of training (end of intervention)
Secondary	NASA task load index (NASA-TLX)		After 20 days of training (end of intervention)