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

NCT05728840 | Recruiting DMC

• 1 other identifier: MFOCUS-1
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Attention Disorder

Keywords

stroke; attention; executive functions; virtual reality; neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Test of Attentional Performance (TAP)

  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)

  Before the intervention (baseline), after 20 days of training (end of intervention), 3-4 and 6-12 months after the end of intervention

• 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

• 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

• 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

Study Arms (3)

Rehabilitation intervention group

EXPERIMENTAL

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

Dose-match control group

ACTIVE COMPARATOR

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

Retrospective standard of care group

NO INTERVENTION

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.

Interventions

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.

Dose-match control group

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.

Rehabilitation intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mindmaze SA: lead
• University of Lausanne Hospitals: collaborator

Study Sites (1)

University of Lausanne Hospitals

Lausanne, 1015, Switzerland

RECRUITING

MeSH Terms

Conditions

Stroke; Cognition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sonia Crottaz-Herbette

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Crottaz-Herbette

CONTACT

+41213149348; sonia.crottaz-herbette@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 15, 2023
• Study Start: February 15, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)