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Spatial Cognition Assessment in Virtual Reality (CogSpa-VR)

Primary Purpose

Spatial Neglect

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spatial cognition assessment
Sponsored by
Université Paris Cité
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Spatial Neglect focused on measuring spatial neglect, virtual reality, assessment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: unilateral right stroke Exclusion Criteria: epilepsy / migraine craniotomy major sensory/motor deficit severe cognitive impairment

Sites / Locations

  • Université Paris CitéRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spatial cognition assessment

Arm Description

A single session of spatial cognition assessment (baseline) will be proposed to participants. This assessment will be based on paper-and-pencil tasks and immersive virtual reality tasks (with an HTC Vive Pro Head-Mounted-Display). The assessment will last around 1 hour.

Outcomes

Primary Outcome Measures

Omissions in cancellation tasks
Number and localization in space
Deviation in line bisection tasks
Deviation of the bisection from the true center of the lines (in mm)
Number of the cubes in each side of space in the Baking Tray Tasks
16 cubes have to be disposed
Detections in the localization tasks
Number and localization in space

Secondary Outcome Measures

Duration of eye fixation in each side of space during VR tasks
Collected thanks to the VR headset
Completion time of each task
(in s)
Score in the Catherine Bergego Scale (CBS)
Functional assessment scored by the occupational therapists. Minimum: 0 / Maximum: 30 / Higher scores mean a better outcome

Full Information

First Posted
January 3, 2023
Last Updated
February 9, 2023
Sponsor
Université Paris Cité
Collaborators
Hopitaux de Saint-Maurice, Université Paris-Saclay
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1. Study Identification

Unique Protocol Identification Number
NCT05723146
Brief Title
Spatial Cognition Assessment in Virtual Reality
Acronym
CogSpa-VR
Official Title
Spatial Cognition Assessment in Virtual Reality
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Paris Cité
Collaborators
Hopitaux de Saint-Maurice, Université Paris-Saclay

4. Oversight

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

5. Study Description

Brief Summary
Unilateral spatial neglect (USN) is a highly-prevalent neuropsychological syndrome following a cerebral stroke characterized by massive impairments in daily life. The evaluation and the rehabilitation of USN encounter many limits whereas immersive virtual reality (VR) could be an efficient tool to go through these limits by imitating an environment of perception and action very close to the real one. The investigators will test a multisensory battery of evaluation based on VR for the diagnostic of USN.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spatial Neglect
Keywords
spatial neglect, virtual reality, assessment

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
60 patients with right stroke will be included in this study: a group of 30 patients with USN will be compared to a group of 30 patients without USN.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spatial cognition assessment
Arm Type
Experimental
Arm Description
A single session of spatial cognition assessment (baseline) will be proposed to participants. This assessment will be based on paper-and-pencil tasks and immersive virtual reality tasks (with an HTC Vive Pro Head-Mounted-Display). The assessment will last around 1 hour.
Intervention Type
Behavioral
Intervention Name(s)
Spatial cognition assessment
Intervention Description
The intervention will be composed of tasks assessing spatial cognition in a real environment (cancellation task, line bisection and baking tray task) and in a virtual environment (cancellation task, line bisection, baking tray task and localization tasks).The Catherine Bergego Scale (questionnaire) will also be used.
Primary Outcome Measure Information:
Title
Omissions in cancellation tasks
Description
Number and localization in space
Time Frame
Baseline
Title
Deviation in line bisection tasks
Description
Deviation of the bisection from the true center of the lines (in mm)
Time Frame
Baseline
Title
Number of the cubes in each side of space in the Baking Tray Tasks
Description
16 cubes have to be disposed
Time Frame
Baseline
Title
Detections in the localization tasks
Description
Number and localization in space
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Duration of eye fixation in each side of space during VR tasks
Description
Collected thanks to the VR headset
Time Frame
Baseline
Title
Completion time of each task
Description
(in s)
Time Frame
Baseline
Title
Score in the Catherine Bergego Scale (CBS)
Description
Functional assessment scored by the occupational therapists. Minimum: 0 / Maximum: 30 / Higher scores mean a better outcome
Time Frame
Assessed within the same week as Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: unilateral right stroke Exclusion Criteria: epilepsy / migraine craniotomy major sensory/motor deficit severe cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alma Guilbert, PhD
Phone
+33176533178
Email
alma.guilbert@u-paris.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alma Guilbert
Phone
+33176533178
Email
alma.guilbert@u-paris.fr
Facility Information:
Facility Name
Université Paris Cité
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alma Guilbert

12. IPD Sharing Statement

Plan to Share IPD
No

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Spatial Cognition Assessment in Virtual Reality

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