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

Primary Purpose

Stroke, Attention Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Immersive virtual reality gamified cognitive activities
Double neuropsychological standard activities
Sponsored by
Mindmaze SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, attention, executive functions, virtual reality, neurorehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Lausanne HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Rehabilitation intervention group

Dose-match control group

Retrospective standard of care group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in Test of Attentional Performance (TAP)
Main deficit of Attention

Secondary Outcome Measures

Test of Attentional Performance (TAP)
Main deficit of Attention
Test of Attentional Performance (TAP)
Other deficits of attention
Wechsler Memory Scale (WMS-III)
Brief Visuospatial Memory Test (BVMT)
Stroop test
Rating Scale of Attentional Behaviour (RSAB)
Catherine Bergego Scale (CBS)
Stroke impact Scale (SIS)
Far space attention: Hemineglect far space Immersive VR-based task
Response to saliency: Immersive VR-based free-viewing exploration (FVE-VR) task
Credibility/Expectancy Questionnaire (CEQ)
Fatigue: Penner questionnaire
Immersive VR-based attentional performance task
Defense Automated Neurobehavioral Assessment (DANA)
User Engagement Scale (UES)
NASA task load index (NASA-TLX)

Full Information

First Posted
January 26, 2023
Last Updated
April 3, 2023
Sponsor
Mindmaze SA
Collaborators
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT05728840
Brief Title
Virtual-reality Exercises for Alleviating Attention Deficits in Patients With Acquired Brain Injury
Official Title
Virtual-reality Exercises for Alleviating Attention Deficits in Patients With Acquired Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mindmaze SA
Collaborators
University of Lausanne Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Attention Disorder
Keywords
stroke, attention, executive functions, virtual reality, neurorehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose-match control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Retrospective standard of care group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Immersive virtual reality gamified cognitive activities
Intervention Description
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
Intervention Name(s)
Double neuropsychological standard activities
Intervention Description
This intervention will include 20 sessions of training using a standard neuropsychological rehabilitation program, in addition to the standard of care.
Primary Outcome Measure Information:
Title
Change from baseline in Test of Attentional Performance (TAP)
Description
Main deficit of Attention
Time Frame
Before the intervention (baseline) and after 20 days of training (end of intervention), within 7 weeks from first day of training
Secondary Outcome Measure Information:
Title
Test of Attentional Performance (TAP)
Description
Main deficit of Attention
Time Frame
Before the intervention (baseline), after 10 days of training (mid-training), 3-4 and 6-12 months after the end of intervention
Title
Test of Attentional Performance (TAP)
Description
Other deficits of attention
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
User Engagement Scale (UES)
Time Frame
After 20 days of training (end of intervention)
Title
NASA task load index (NASA-TLX)
Time Frame
After 20 days of training (end of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sonia Crottaz-Herbette
Phone
+41213149348
Email
sonia.crottaz-herbette@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Crottaz-Herbette
Organizational Affiliation
University of Lausanne Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Lausanne Hospitals
City
Lausanne
ZIP/Postal Code
1015
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Crottaz-Herbette
Phone
+41213149348
Email
sonia.crottaz-herbette@chuv.ch

12. IPD Sharing Statement

Plan to Share IPD
No

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

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