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

NCT ID: NCT05728840

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2026-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Immersive virtual reality gamified cognitive activities

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Double neuropsychological standard activities

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: collaborator

Mindmaze SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonia Crottaz-Herbette

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Locations

University of Lausanne Hospitals

Lausanne, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Sonia Crottaz-Herbette

Role: CONTACT

sonia.crottaz-herbette@chuv.ch

+41213149348

Facility Contacts

Sonia Crottaz-Herbette

Role: primary

sonia.crottaz-herbette@chuv.ch

+41213149348

Other Identifiers

MFOCUS-1

Identifier Type: -

Identifier Source: org_study_id